Malaria BCG

MARKET ASSESSMENT FOR MALARIA VACCINES
January, 2005
ACKNOWLEDGEMENTS
Malaria market assessment study sponsored by
With funding from
70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt -1-

TABLE OF CONTENTS
Project overview
Endemic country findings

• Malaria burden
• Public market
• Private market
Travelers and military findings
Demand model methodology
Predicted vaccine market size
Implications and next steps
Appendix
OVERALL STUDY OBJECTIVE: ACHIEVING BETTER
UNDERSTANDING OF THE DEMAND FOR MALARIA VACCINES
Project
Project objectives
objectives
Create platform of knowledge that connects scientists, industry leaders, and donors with
Connect end users in countries afflicted by malaria
stakeholders • Critical to ensure that what gets developed is what countries want
• Make need for vaccine concrete in eyes of industry donors
Obtain more complete information about the need for a malaria vaccine to inform decision
Inform making and throw light on the decision-making “black-box”
decisions • Understand hurdles and constraints to enable most rapid uptake possible
• Evaluate key risks and uncertainties
- manufacturing capacity and capital investments required
- design of clinical trials
- “fair value” agreements
- portfolio management
- how to attract biopharma companies to invest in malaria vaccine R&D
Project
Project stems
stems from
from MVI’s
MVI’s mission
mission to
to accelerate
accelerate the
the development
development of of promising
promising
malaria
malaria vaccine
vaccine candidates
candidates and
and to
to ensure
ensure their
their availability
availability in
in the
the developing
developing world
world
INCLUDES PUBLIC AND PRIVATE MARKETS IN MALARIA-ENDEMIC
AREAS OVER TIME AND ACROSS DIFFERENT POSSIBLE PRODUCTS
Project scope covers broad range of populations Flexibility built into design so that project
and endemic geographies from 2010 to 2025 broadly relevant for malaria vaccine community
Analysis for malaria vaccines in general, not for

Population
any one specific vaccine
• Overall evaluation of demand drivers and
Endemic – Private market
Endemic – Public market
adoption hurdles
Africa
• Includes demand forecasting and “tipping
Travelers points” for various product profile scenarios
(e.g., duration, efficacy, cost)
Military
Geography
SE Asia
Market assessment conducted at one point in

South time, but structure allows ongoing insights to be
America developed as new information becomes
available
• Attributes of a vaccine
Time • Attitudes with respect to particular product
profile requirements
• Funding available for malaria

PROJECT DRIVEN BY
DEMAND LEAKAGE FRAMEWORK
Need Product Access Attitude
Description Number of people Number of people Number of people Number of people

who would benefit for whom this with access to likely to get
from a malaria vaccine suitable medical care and vaccinated given
vaccine able to pay for government/personal
vaccination stance and
vaccination strategies
Example • Size of population • Species (P. • Country healthcare • Government support

factors with significant falciparum or P. expenditure per of current
malaria mortality vivax) capita prevention and
and disease burden • Pediatric indication • Infrastructure, e.g., treatment
• Size of traveler beds per 1000 people • Individual
population • Percent of children compliance with
• Size of relevant under 12 vaccinated current prevention
military population for measles and treatment

DEMAND LEAKAGE FRAMEWORK IMPLEMENTED
VIA THREE-PHASED APPROACH
Conducted Across Both Endemic Countries and Special Populations
Conduct landscape scan Develop market insight Synthesize findings and

of existing sources through primary research construct demand model
Objective Situation analysis for Evaluation of demand Model future demand for
endemic countries and drivers and barriers vaccine, including
select populations scenarios analysis and key
sensitivities
• Review secondary sources • Primary research in 8 • Conduct additional

Key
for endemic countries (e.g., endemic countries interviews as necessary
activities
malaria burden, EPI uptake, • Primary research with • Synthesize findings
demographics) travel medicine specialists • Develop interactive model
• Identify and study analogs and military experts to estimate vaccine
• Perform cluster analysis to • Primary research with demand
segment countries donors, policymakers, and • Run scenarios and
• Generate product profile for KOLs sensitivities on model
primary research output
Project
Project completed
completed over
over 20
20 weeks
weeks in
in 2004-5
2004-5

PRIMARY INTERVIEWS FOCUSED ON MALARIA-ENDEMIC
REGIONS ACROSS THE GLOBE
Included Both P. vivax and P. falciparum Endemic Regions
Malaria-endemic regions are geographically P. falciparum of increasing importance in

concentrated Africa and SE Asia
Africa dominated by P. falciparum

• 5 to 10% of cases are P. vivax
• Increasing drug resistance to this
5% more severe species makes P.
falciparum a focus area
8%
0.1% Growing importance of P. falciparum in
India
• 20% of cases in 1980 to 45% in 2000
P. falciparum accounts for nearly 80%

1%
85% of cases in the Mekong region of SE
Asia
Eastern Europe, Caucasus, and Brazil

predominantly P. vivax
% of malaria
deaths
Note: WHO Southeast Asia Regional Office estimates that 70-75% of malaria deaths are from Sub-Saharan Africa due to changing malaria conditions and under-reporting
Source: WHO (map), Arrow et al., Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance; Mekong Malaria II, The Southeast Asian Journal of
Tropical Medicine and Public Health, Vol. 34 (4) 2003, Lancet; BCG Interviews
EIGHT LOCATIONS CHOSEN TO MAXIMIZE EXPOSURE TO NEED,
ACCESS, AND ATTITUDES OF MALARIA-ENDEMIC COUNTRIES
Countries chosen to balance
Over 200 interviews conducted
selection across key criteria
Quadrant I: Quadrant II:

Moderate potential High potential
High demand? demand?
Country C
Need: Country A
• Population at Country B
risk
• Malaria Country G Country F
burden Quadrant III:
Country H
Moderate
• Transmission
Country D potential
setting Country E demand?
Low
Quadrant IV:Low High

Low potential
demand Access/ attitude:
• Malaria readiness Brazil Ghana India
• Health care expenditure Mozambique Thailand
• Number of physicians Nigeria
• Presence of clinical site Senegal
• Geography / culture Tanzania
P. falciparum predominant
P. vivax and P. falciparum predominant Primary research countries
P. vivax only predominant
Note: Complete list of interviewees can be found in the appendix
IN ADDITION, PRIMARY RESEARCH CONDUCTED WITH DONORS,
POLICYMAKERS AND MILITARY AND TRAVELERS EXPERTS
Sample endemic Sample donor and Sample military Sample travelers

country interviews policymaker interviews interviews interviews
Ministry of Health Senior Technical Advisor Science Director, Walter Senior Lecturer, London
for Immunization, USAID Reed Army Institute of School of Hygiene and
Ministry of Finance Research (WRAIR) Tropical Medicine
Health Advisor, DFID
WHO Director, Army Malaria Director, Travel Clinic,
Senior Health Specialist, Vaccine Program Massachusetts General
Academic researcher World Bank Hospital
Former Director, Division
Hospitals Secretariat, Roll Back of Communicable Diseases Director, Center for Travel
Malaria and Immunology (WRAIR) and Tropical Medicine
Director of Health, Multi- (Toronto)
national corporations
More
More than
than 200
200 in-country
in-country and
and 30
30 global
global interviews
interviews conducted
conducted
Note: Complete list of interviewees can be found in the appendix
FINDINGS INCORPORATED INTO AN ADAPTIVE
MODEL USED TO PREDICT VACCINE DEMAND
Sample Information Flow – Does Not Represent Full Scope of Model
Scenario
Scenario drivers
drivers Model
Model logic
logic Modular
Modular outputs
outputs
Demand over time

Data Attitudinal Attitudinal
Efficacy inputs inputs algorithms
2010 2011 2025
Age, birth Include
cohort country X
Duration if efficacy >
Y Demand by geography
GDP, income S
Africa SE Asia
America
Cost
Include
military Demand by population
Malaria if duration >
incidence Z Traveler
Funding Public Private
Military
Model
Model has
has flexibility
flexibility to
to accommodate
accommodate changes
changes in
in vaccine
vaccine
landscape
landscape and
and country
country characteristics
characteristics over
over time
time
70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt - 10 -
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
MALARIA IS ONE OF THE WORLD’S MOST COMMON
AND MOST DEADLY PARASITIC DISEASES
Malaria transmission cycle Basic facts
Population at risk – malaria is endemic in 117

countries; 2.5 B people are at risk (40% of
world’s population)
Morbidity – malaria infects a minimum of 300 to

500 MM people per year
Mortality - between 1 and 2 MM people die

annually from malaria, mostly children under 5 in
rural areas
Health care – at least 10% of hospitalizations and

20-60%(1) of doctor visits in Africa are caused by
malaria
Costs – real costs in Africa are $1.8 B annually;

lost GDP of $12 B per year due to malaria
(1) WHO estimates 20-30%, but in-country primary research cites 40-60%
Source: WHO 2002
PRIMARY MALARIA BURDEN DRIVEN BY
P. FALCIPARUM AND P. VIVAX
P. falciparum Increasing Its Impact Across Both Asia And Africa
Plasmodium characteristics In addition to its prevalence in Africa, P. falciparum also

dominates in Mekong region of SE Asia
P. falciparum
• Responsible for most Malaria deaths, especially in 1,600
Africa 34 7
• Infection can develop suddenly and produce several 1,400 14
life-threatening complications 29 2 vivax
10 156 289
Malaria cases in 2003 (000s)

• Almost always treatable if treatment started promptly 1,200
• Infects RBCs in all stages of development
235
1,000 62
P. vivax
• Geographically widest spread, yet mostly found in the
tropics, especially throughout Asia 800 196
• Produces less severe symptoms
• Relapses for up to 3 years possible, and chronic 600 162 1,132 falci-
Myanmar and Vietnam parum
disease is debilitating together contribute to
• Infects only young RBCs 400 ~ 60% of malaria
• More likely to affect both adults and children cases in the Mekong
514
200 region
P. malariae
• Wiped out from temperate climates, but still in Africa 0
Vietnam Cambodia China/
P. ovale Myanmar Laos Thailand Yunan Total
• Rare, and generally occurs in West Africa
P.
P. falciparum
falciparum of
of growing
growing concern
concern in
in both
both Africa
Africa and
and Asia
Asia due
due to
to increasing
increasing drug
drug resistance
resistance
Source: BCG Interviews, Mekong Malaria II, The Southeast Asian Journal of Tropical Medicine and Public Health, Vol. 34 (4) 2003, Lancet
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
ENDEMIC COUNTRY DEMAND LARGELY DRIVEN BY
PUBLIC MARKET
• Population of • Product profile • Coverage of • Decision

Public
endemic target pop. making and
market
country • Donor funding attitudes of
• Hurdles to government,
adoption KOLs
Private • Population of • Product profile • Private clinic • Individual

market endemic access attitudes
country • Income levels
• Travelers to • Product profile • Seek advice • Prefer vaccine

Travelers endemic before traveling vs. prophylaxis
countries
• Worldwide • Product profile • Military budget • Vaccinate all vs.

Military militaries deploying vs.
none
THROUGHOUT OUR PRIMARY RESEARCH, STAKEHOLDERS
RECOGNIZED THE SIGNIFICANT IMPACT OF MALARIA
Malaria
Malaria is...
is...
...a primary health issue ...a high cost burden
“...one of the most important

vector borne diseases in
“...estimated to result in
Thailand” – MoPH Thailand
productivity loss of 1 – 3 % of
GDP” – Ghana MoH
“...the most important vector borne

disease from a public burden
perspective in India” - NVBDCP “...estimated to cost US$ 1 Bn per
year to the country in terms of
economic productivity” – Nigeria
Dept of Public Health
“...the primary public health crisis
in Senegal” – BASICS Senegal
...a
...a huge
huge problem
problem -- Mozambique
Mozambique MoH
MoH
Note: NVBDCP stands for National Vector Borne Disease Control Program
Source: BCG interviews, BCG analysis
THE UBIQUITOUS NATURE OF THE DISEASE IN AFRICA
PRESENTS A UNIQUE SET OF ISSUES
Malaria is so common in Africa Those hardest hit by malaria in Malaria is being overshadowed
that it can lead to complacency Africa, are often disenfranchised by HIV, particularly in East Africa
• Frequency of deaths • Infants, young children, and • HIV/AIDS hits adults much
desensitizes the population pregnant women, who lack harder than malaria
semi-immunity of adults, are
• Long history of the disease -though malaria is often
most affected
results in health workers the cause of death
feeling it is routine • These groups have the
• HIV/AIDS receives a greater
smallest voice in health policy
share of health funds
“Children, who are worst

“People accept it as affected by malaria, do not
part of life” –DFID have a voice in the political “A lot of money is being
system” – Ghana Health poured into HIV/AIDS” – World
Service Bank Tanzania
“The frequency of child
deaths is so high that it
“Malaria primarily targets “There’s a limited pot of
is commonplace” –
children and pregnant women, money for healthcare, and
World Vision Senegal
who are not the decision- HIV is attracting the
makers” – Mozambique MoH resources” – UNICEF Moz.
As
As aa result,
result, malaria
malaria can
can lack
lack the
the human
human capital,
capital, financial
financial resources,
resources,
and
and political
political energy
energy itit might
might warrant
warrant based
based onon its
its impact
impact
IN COUNTRIES SUCH AS INDIA, THAILAND AND
BRAZIL, THE IMPACT OF MALARIA IS MORE CONTAINED
Malaria
Malaria is
is aa problem
problem in
in India,
India, though
though high
high Malaria
Malaria also
also aa problem
problem in
in Thailand
Thailand and
and Brazil,
Brazil, but
but morbidity
morbidity is
is now
now
burden areas are geographically concentrated
burden areas are geographically concentrated low and the disease burden has been restricted to border areas
low and the disease burden has been restricted to border areas
“We saw malaria “Reported malaria cases

“~10 – 15% of the population is at were close to 500,000
incidence rising in the
sufficient risk from malaria to warrant cases in 1980s, but now are
1990s, so in 1999 we
intensive control programs” – WHO less than 30,000 a year”
decided to make this a
priority” – MOH, Brazil – Trop. Med. Thailand
“Malaria control is the oldest

and largest national vertical “Malaria in Thailand is now
health program in the country” well-controlled, except in the
– MoHFM India Thai-Myanmar and Thai-
Cambodia border regions” –
Trop. Med. Thailand
But
But the
the concentration
concentration of of malaria
malaria inin border
border or
or remote
remote locations
locations in
in these
these countries
countries
can
can create
create aa different
different set
set of
of political
political challenges
challenges for
for diagnosis,
diagnosis, prevention
prevention and
and treatment
treatment

CURRENT INTERVENTIONS COMBINE
PREVENTION AND TREATMENT
Prevention includes spraying, environmental Treatment focuses on early recognition and
cleaning, ITNs and IPT accurate diagnosis and treatment
Early recognition: Educate patients to recognize

Spraying: outdoor and indoor symptoms early and promptly seek treatment
based on vector resting location • Education in schools, health facilities
• Home info packets
Environmental clean-up: removal

of standing water; seeding of
larvivorous fish Accurate diagnosis: Ensure correct diagnostic
techniques are available
• Increasing access to health facilities (clinics,
ambulances, pharmacies)
ITNs: insecticide treated bed nets
for children < 5 and pregnant
women
Accurate treatment: Drug therapy according to resistance
of the region and plasmodium species
IPT: intermittent presumptive • CQ often limited by resistance
treatment for pregnant women, • SP often first-line, but facing growing resistance
IPTi for infants • ACT use increasing, but facing supply problems
Portfolio
Portfolio approach
approach to
to intervention
intervention likely
likely to
to continue
continue
Source: BCG interviews, BCG analysis, WHO Africa Malaria Report 2003
FOCUS ON PREVENTION VS. TREATMENT VARIES BY GEOGRAPHY
Most African Countries Emphasize Prevention while
More Developed Countries Promote Early Diagnosis and Treatment
Strategy Population at risk Diagnosis and

Donor perspective Prevention
Area and attitude treatment
• Children under 5 and • Some funds for • ITN subsidies • First line varies (CQ,
pregnant women most subsidized ITN, IPT, • IPT with SP piloted SP and Amodiaquine)
vulnerable ACT, etc facing resistance
Africa • Lower focus on
• Majority of country • Shift to ACTs
• Common disease: part spraying and clean-up • Limited diagnostic
of daily life equipment
• Adults and children • Wealthier countries • Residual spraying in • Rapid diagnosis /
• Biggest problem in less reliant on donor selected districts presumptive treatment
border areas support • Use of larvivorous fish based on geography
SE Asia to control vector • High resistance; some
• Focus of local govt
must use ACT first line
• Adults and children • Wealthier countries • Spraying & clean-up in • Faster response from
• Biggest problem in less reliant on donor high risk/border areas diagnostic facilities
border areas support • No ITN, indoor spray • Species specific
South America
• Perceived to be “under due to outdoors- treatment
control” resting vector • Goal: treatment within
24 hours
Difficulty
Difficulty in
in controlling
controlling malaria
malaria burden,
burden, especially
especially in
in Africa
Africa
SIX CHARACTERISTICS OF PRODUCT
PROFILE ARE KEY DEMAND DRIVERS
Efficacy
Efficacy Duration
Duration of
of
•• Clinical
Clinical action
action
•• Severe
Severe
Administration
Administration Malaria
•• Dosage
Dosage vaccine Cost
Cost
•• Schedule
Schedule product
•• Boosters
Boosters profile
Population
Population Targeted
Targetedspecies
species
•• Age
Age •• P.
P. falciparum
falciparum
•• Pregnancy
Pregnancy •• P.
P. vivax
vivax
•• Other
Otherdiseases
diseases •• Other
Other

PUBLIC MARKET VACCINE MUST BE COST EFFECTIVE,
FINANCIALLY SUSTAINABLE, AND EASY TO ADMINISTER
Attribute Impact on demand Details Comments
• Minimum efficacy desired against Countries will compare

Efficacy High
High clinical disease vary from 30% in W efficacy against ITNs and
Africa to 50% in E Africa to 80% in SE other preventative tools
Asia
Benefit of protecting children
• Duration factors into cost effectiveness early in life, until they
Duration Medium
Medium - minimum of 1 year develop partial immunity
Duration impacts cost

• Cost/efficacy needs to compete with
existing interventions Financial sustainability a
Cost High
High • May require donor funding, but huge issue
countries need sustainable solution
We’re most concerned about
P. falciparum—it is the most
Species High
High • P. falciparum most important in Africa deadly
and Asia vs. P. vivax in Brazil
Population • Relevant to infants, children, and Pregnant women and under

Low
Low
segment pregnant women in Africa vs. adults in fives are highest priority
SE Asia, S America
Only realistic way to
implement vaccine is
Administration High
High • Prefer to give vaccine with existing EPI
through EPI schedule
schedule

STAKEHOLDERS ACROSS COUNTRIES AGREE ON REQUIREMENTS
FOR CERTAIN PRODUCT PROFILE CHARACTERISTICS
Malaria
Malaria Endemic
Endemic Countries
Countries
Most
Most stakeholders
stakeholders agree
agree that
that ~1
~1 year
year minimum
minimum acceptable
acceptable
•• Yearly
Yearly boosters
boosters acceptable,
acceptable, but
but bring
bring significant
significant concerns
concerns for
for costs
costs and
and compliance
compliance in
in rural
rural and
and
Duration border populations
border populations
-- booster
booster frequency
frequency will
will impact
impact cost/benefit
cost/benefit assessment
assessment
-- extending
extending duration to 2 years could significantly increase
duration to 2 years could significantly increase coverage
coverage and
and reduce
reduce costs
costs
Almost
Almost universal
universal view
view that
that vaccine
vaccine should
should be
be included
included in
in EPI
EPI program
program
•• Most
Most prefer
prefer adhering
adhering toto existing
existing EPI
EPI timing
timing
Administration -- some
some openness
openness to to changing
changing schedule
schedule forfor efficacious
efficacious vaccine
vaccine
•• Vaccination
Vaccination campaigns may be used in Thailand and Brazil to
campaigns may be used in Thailand and Brazil to reach
reach adult
adult target
target population
population
•• Injection
Injection not
not an
an issue,
issue, although
although oral
oral is
is preferred
preferred and
and would
would increase
increase compliance
compliance
Safety Across
Across all
all countries,
countries, safety
safety universally
universally important
important but
but also
also “assumed”
“assumed”

VACCINE RELEVANT FOR HIGH-RISK POPULATIONS IN AFRICA VS.
TOTAL POPULATION IN HIGH-RISK AREAS IN SE ASIA / S AMERICA
Africa
Africa SE
SE Asia
Asia // S
S America
America
•• Entire
Entire countries
countries considered
considered malaria-endemic
malaria-endemic •• In
In Brazil,
Brazil, Thailand,
Thailand, India,
India, etc,
etc, malaria
malaria only
only
present
present inin border
border areas
areas
•• Adults
Adults develop
develop partial
partial immunity
immunity toto disease
disease
Population -- children
children under
under five
five and
and pregnant
pregnant women
women •• Vaccine
Vaccine considered
considered relevant
relevant and
and appropriate
appropriate
in
in greatest
greatest need
need for
for all age groups in India and Brazil and
all age groups in India and Brazil and
-- government primarily
primarily adults
adults in
in Thailand
Thailand
government cover
cover for
for adults
adults unlikely
unlikely
•• HIV
HIV positive adults priority in some countries
positive adults priority in some countries
Tanzania Brazil
Vaccine Lake
Victoria
Vaccine Macapa
relevant to relevant to Belem
Serengeti
children National Park
Kilimanjaro
all age Man Aus
Amazon River
Fortaleza
under 5 Tarangire
groups in Porto Velho
Natal
Recife
throughout Lake Tanganyica National Park Amazon Brasilia
country Dodoma
Zanzibar
area Salvador
Dar Es
Lake Rukwa Salaam
Ruahu Sao Paulo
National Park
Rio De Janeiro
Lake
Malawi Selous
Game Reserve Porto Alegre
Note: SE Asia / S America represented in interviews by India, Thailand, and Brazil

Source: BCG interviews, BCG Analysis
EFFICACY AND COST HURDLES DIFFER FOR AFRICAN
COUNTRIES VS. SE ASIA / S AMERICA
Africa Typically Has Lower Efficacy Requirement and Higher Cost Sensitivity
Africa
Africa SE
SE Asia
Asia // S
S America
America
•• Impact
Impact on
on clinical
clinical disease
disease critical
critical •• Impact
Impact on on clinical
clinical disease
disease very
very important
important
•• Impact
Impact on
on severe
severe disease
disease may
may not
not influence
influence -- Thailand
Thailand focused
focused onon severe
severe disease
disease
introduction
introduction decisions
decisions efficacy
efficacy due
due to
to increasing
increasing drug
drug resistance
resistance
Efficacy
•• RTS,S
RTS,S data
data viewed
viewed as
as promising
promising •• P.
P. falciparum
falciparum more
more important
important toto India
India and
and
•• W.
W. Africa hurdle: ~30% against
Africa hurdle: ~30% against clinical
clinical and
and Thailand;
Thailand; P.P. vivax
vivax more
more important
important to to Brazil
Brazil
~50%
~50% against
against severe
severe disease
disease •• Hurdle:
Hurdle: ~80-90%
~80-90% against
against clinical
clinical disease
disease
•• E.
E. Africa
Africa hurdle:
hurdle: ~50%
~50% against
against clinical
clinical
•• Population
Population expects
expects vaccine
vaccine to
to be
be free
free •• Wealthier
Wealthier governments
governments expected
expected toto purchase
purchase
-- majority
majority of
of population
population cannot
cannot afford
afford even
even vaccine;
vaccine; donors important in poorer nations
donors important in poorer nations
$1-3/dose
$1-3/dose -- Thailand:
Thailand: $10-20
$10-20 // dose
dose affordable
affordable
•• Governments
Governments willwill evaluate
evaluate cost
cost effectiveness
effectiveness -- India:
India: cost
cost of
of rolling
rolling out
out to
to even
even high
high risk
risk
Cost of
of vaccine
vaccine vs.
vs. malaria
malaria control
control portfolio
portfolio groups
groups would
would be be prohibitive
prohibitive
•• Donor
Donor funding
funding critical
critical •• Governments
Governments will will evaluate
evaluate cost/benefit
cost/benefit of
of
•• Some
Some countries
countries will
will refuse
refuse upfront
upfront financing
financing vaccine
vaccine vs.
vs. malaria
malaria control
control portfolio
portfolio
without
without clear
clear path
path to
to sustainability
sustainability •• Some
Some countries
countries will
will refuse
refuse upfront
upfront financing
financing
without clear path to sustainability
without clear path to sustainability

ENDEMIC COUNTRIES’ ABILITY TO PURCHASE VACCINE IS
HEAVILY CORRELATED WITH DONOR FUNDING
Developing economies rely heavily on donor More developed economies receive (and
funding for health programs need) less donor support
• Many African and SE Asian countries fund a • Developed economies cover most of their budgets
majority of their budgets with donor support with internal funds
• High disease burden in these countries translate to • Organizations such as the World Bank are less likely
large amounts of funding dedicated towards the to give low-cost loans to developed economies
health budget
“The general funds that the “~ 50% of our overall

budget and more than “Thailand is now considered
Senegal MoH uses to fund its
50% of health a well established economy
operations can come from
spending is donor- and ‘too rich’ to need outside
international donors like the
funded” support”– NSTDA
World Bank or the EU”
“In India, NGOs and donor organizations have

a very limited role in malaria control; less than
5% of expenses for malaria are from donors”
Funding
Funding sustainability
sustainability will
will drive
drive demand
demand for
for less
less wealthy
wealthy countries
countries
FUNDING DECISIONS MADE VIA ITERATIVE PROCESS, OFTEN
BASED ON WHO GUIDELINES AND KOL RECOMMENDATIONS
Key influencers besides WHO,
UNICEF, GAVI, and the MoH are There are targets for high-
university professors and priority sectors like health
academics –NGO, Senegal General Funding Methodology – NGO, Mozambique
Donor strategies and priorities

Technical recommendations from WHO and KOLs
Negotiations with
Budget Requests Early Allocations Final allocations
countries, organizations
Based on requests,
Countries MOH/MOF Countries and/or local
priorities, and budget, Final grants are made to
and/or local donor donor offices negotiate
early allocations are countries and
offices make requests to needs, allocation, and
made into broad organizations
headquarters timing with headquarters
spending categories
Local offices make Regional teams

funding requests ~2 It’s all about information; determine priorities and The local office works
years in advance of sometimes the countries resource allocation for with national government
expected receipt - don’t know what will and each country through to allocate money within
USAID won’t be approved - negotiation with MOF, country to highest need
Global Fund MOH, and other local areas - UNICEF
planning groups -WB
Highly
Highly collaborative
collaborative approach
approach translates
translates to
to donors
donors making
making few
few
independent evaluations of new technologies or interventions
independent evaluations of new technologies or interventions
MALARIA VACCINE SEEN AS PROMISING, BUT WOULD SHARE
AVAILABLE DONOR RESOURCES WITH EXISTING INTERVENTIONS
Donors
Donorsare
arehighly
highlyinterested
interestedin
in ...but
...buttotal
totalfunding
fundingunlikely
unlikelyto
to ..and
..andcurrent
currentsolutions
solutionsare
are
aavaccine...
vaccine... increase drastically
increase drastically unlikely to disappear
unlikely to disappear
• Donors routinely cite a vaccine as • Total malaria and vaccine funding • Current tactic of portfolio approach
a very exciting possibility may not change with partial to malaria unlikely to disappear
efficacy vaccine with vaccine introduction
• Donors fund significant amounts of
vaccine R&D
“DFID maintains an “No one measure is a

“There is only one pot of magic bullet—need to work
active interest in
money for all healthcare with what we have” -USAID
vaccine research” -
interventions” -UNICEF
DFID
“USAID dollars given to the “We would not want to see a

“A vaccine will be a very
Vaccine Fund will likely not vaccine hindering the use of ITNs;
attractive investment for the
increase in response to a new the world has worked so hard to
donor community” -USAID
malaria vaccine” -USAID get people to use them” -USAID
Allocation
Allocation of of funding
funding within
within prevention
prevention and
and control
control
portfolio
portfolio likely
likely to
to be
be determined
determined byby vaccine
vaccine product
product profile
profile
EXISTING EPI COVERAGE SHOWS NUMBER
OF PEOPLE POTENTIALLY VACCINATED
EPI Program Is An Effective Tool For Reaching Vaccine Recipients
EPI program coverage by geography EPI coverage of 20 most populous African countries
# of 50 % 100
countries coverage
45 90
40 80
35 70
30 60
25 Europe 50
E. Mediterranean
40
20 SE Asia
Americas 30
15
W. Pacific
20
10 Africa
10
5
0
0
Uganda
Ghana
Ethiopia
Kenya
Guinea
Angola
Chad
Niger
South Africa
Zambia
Nigeria
Mali
Burkina Faso
Algeria
Malawi
Senegal
Madagascar
Mozambique
Zimbabwe
Cameroon
< 60 60 to 70 70 to 80 80 to 90 90 to 100
EPI % coverage
Source: BCG interviews, BCG Analysis, SIS for DPT-3 coverage

EVEN WITH DONOR FUNDING, SOME CONCERN ABOUT KEY
STAKEHOLDERS WILLINGNESS TO ACCEPT A MALARIA VACCINE
8 Reasons Commonly Cited
Reasons for Reduced Interest Rationale Relevant Geographies
No need for a vaccine Countries with better control over malaria may view Brazil, Thailand
1
need for a vaccine as less urgent
Do not trust vaccine due to Community may be less willing to support a new Thailand; Africa—high awareness,
2
prior failure malaria vaccine based on history of SPF66 but less impact due to high burden
Inadequate infrastructure Pragmatic concerns regarding ability to reach Mozambique, Tanzania, Nigeria;
3
population, i.e. staff training, cold chain needs, etc. likely an issue throughout Africa
Do not want to spend for Government unlikely to unilaterally spend money
4
non-nationals on malaria control for migrants and refugees
Need local data to prove Some countries emphasize importance of testing Most countries
5
effectiveness the vaccine in-country
Difficult decision making States or regions highly autonomous in decision- Nigeria, India
6
making, particularly regarding health interventions
Partial efficacy vaccine Vaccinated people who contract malaria could Most countries
7 decrease credibility of entire immunization program
may decrease credibility
Partial efficacy vaccine Must communicate benefit of partial efficacy in Most countries
8
complicates messaging promotion materials and to trainers
Most
Most hurdles
hurdles can
can likely
likely be
be addressed
addressed through
through effective
effective pre-launch
pre-launch planning,
planning,
proactive stakeholder management, and communication
proactive stakeholder management, and communication
INFLUENCE OF GOVERNMENT, KOLS, DONORS, AND NGOS
DIFFERS BETWEEN AFRICA AND SE ASIA / SOUTH AMERICA
Africa
Africa SE
SE Asia
Asia // S
S America
America
• Key role in vaccine introduction • Primary decision-maker for vaccine

Government • Long-standing MOH malaria programs
Government • Health investment decisions made at highest
levels of MoH, often with legislature input • Decentralization key trend, with local
authorities playing an increasing role
• Local experts wield significant influence in • Strong research communities

Key
Key Opinion
Opinion Nigeria, Tanzania, Senegal • Demand for in-country clinical trials
Leaders
Leaders • Foreign experts stronger in Mozambique • Thailand and Brazil: researchers sit on
malaria committees to assist MoH with policy
• Key role in vaccine introduction • Highly self-sufficient

Donors
Donors • Dependence varies by country - India funds ~95%, Brazil and Thailand
• E. Africa concerned with sustainability fund close to 100% of malaria expenses
• WHO plays key role • WHO plays a key role, but less than in Africa
Other
Other - esp. in countries with less human capital - collaborates with govts. on research
• UNICEF, international researchers, GAVI, and projects
others also can be very influential • More limited role for other organizations
Coordinating
Coordinating influencers
influencers across
across geographies
geographies key
key to
to maximizing
maximizing intervention
intervention supply
supply
KEY TAKEAWAYS
Public Market
Significant need for malaria vaccine in public market. Despite breadth of existing alternatives
for prevention and treatment, control perceived to be insufficient in most countries
• Growing need for response to P. falciparum in non-African countries
Minimum product profile varies by geography, however consistent focus on importance of P.

falciparum, one year duration, and safety
• Efficacy requirement highest for clinical disease in SE Asia (80%); lowest in W
Africa (30%)
• Cost important as governments often do not have ability to pay for vaccine
- and public often expects vaccine to be free of charge
Current vaccination infrastructures could support significant uptake – but, donor funding will
be needed to finance vaccine purchase and infrastructure enhancement requirements in
African countries
• Increasing focus on long-term sustainability of donor supported programs
• Wealthier SE Asian / South American countries willing to do more alone
African country governments and donors rely heavily on recommendations from global
scientific community and WHO when making decision about vaccine introduction
• In wealthier SE Asian / South American countries, government and local
stakeholders key
Hurdles vary across geographies, but include perception of need, perceptions of vaccines,
communication and credibility issues for partial effective vaccines and desire for local
clinical data
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
PRIVATE MARKET ALSO RELEVANT IN ENDEMIC COUNTRIES
PUBLIC
PUBLIC • Population of • Product profile • Coverage of • Decision
MARKET
MARKET endemic target pop. making and
adoption KOLs
PRIVATE
PRIVATE • Population of • Product profile • Private clinic • Individual
MARKET
MARKET endemic access attitudes

TRAVELERS
TRAVELERS endemic before traveling vs. prophylaxis
countries

MILITARY
MILITARY militaries deployed vs.
none
PRIVATE MARKET MOST CONCERNED
THAT VACCINE BE HIGHLY EFFICACIOUS
Attribute Impact on demand Details Comments
• Most important factor given need to Private market

Efficacy High proactively seek out vaccine; efficacy acceptance likely with
has to warrant the time and money high efficacy
invested
• Minimum one year

Duration Medium
• Cost less of an issue than in public

Cost Medium Cost of vaccine would
market for wealthy individuals, but still
have to be
significant for groups choosing
comparable to current
among interventions
interventions for use
in the private market
• Vaccine for P. falciparum more
Species High
important given severity of disease
• Private market vaccine applicable to

Population Medium adults as well as other high risk
groups
• Individuals seeking a vaccine in the

Administration Low
private market are more likely to
comply with multiple doses / boosters

PRIVATE MARKET LIKELY SMALL, EXCEPT IN MORE WEALTHY
AND POPULOUS COUNTRIES SUCH AS INDIA
Private market for vaccines appears limited in

Extensive private market for vaccines in India
other countries
# annual India private market volume Cost / # annual Private market volume
doses for select vaccines dose doses for select vaccines
2.5 25 2.5
(MM) ($) (MM)
Brazil
2.0 20 2.0 Thailand
Nigeria
Ghana
1.5 15 1.5
1.0 10 1.0
0.5 5 0.5 0.3

0.2 0.2 0.2
0.03 0.01 0.02 0.01
0.0 0 0.0
MMR Hep B HiB Varicella Hep A Typhoid Hep B HiB
70% of health care spend from private market; Private purchase of vaccines limited to the very
2004 private vaccine market estimated at $65 MM high income class who prefer private facilities
Private
Private market
market in
in African
African countries
countries for
for aa malaria
malaria vaccine
vaccine likely
likely to
to be
be small
small
Source: IMS
HURDLES INCLUDE INADEQUATE INFRASTRUCTURE,
LIMITED CLINIC ACCESS, AND REGULATIONS
•• Africa:
Africa: private
private vaccination
vaccination services
services obtained
obtained through
through private
private clinics
clinics often
often in
in large
large urban
urban areas
areas
•• Brazil
Brazil and
and Thailand
Thailand regions
regions limited
limited to
to border
border areas
areas with
with less
less private
private health
health care
care infrastructure
infrastructure
Infrastructure
•• Private
Private shops
shops selling
selling pharmaceuticals
pharmaceuticals exist
exist in
in all
all primary
primary research
research countries
countries except
except Mozambique
Mozambique
-- usually do not distribute vaccines; may have more limited access to
usually do not distribute vaccines; may have more limited access to cold chain cold chain
•• Clientele
Clientele of
of private
private clinics
clinics tends
tends to
to be
be wealthy
wealthy and
and urban,
urban, typically
typically much
much less
less than
than 10%
10% of
of total
total
Access population
population
•• Regulations
Regulations in
in several
several countries
countries may
may impact
impact viability
viability of
of private
private vaccination
vaccination markets
markets
-- Mozambique:
Mozambique: regulations
regulations limit
limit sale
sale of
of drugs/vaccines
drugs/vaccines to to select
select health
health facilities
facilities and
and
Regulation pharmacies
pharmacies
-- Tanzania:
Tanzania: regulations
regulations prevent
prevent private
private clinics
clinics from
from charging
charging for
for EPI
EPI schedule
schedule vaccines
vaccines
Nigeria
Nigeria likely
likely to
to have
have the
the most
most robust
robust private
private market
market of
of the
the African
African countries
countries researched
researched
•• Even
Even there,
there, infrastructure
infrastructure challenges
challenges would
would need
need to
to be
be addressed
addressed to
to maximize
maximize reach
reach
PRIVATE MARKET ALSO LIMITED IN MANY MALARIA ENDEMIC
COUNTRIES BY AFFORDABILITY AND EFFICACY CONSTRAINTS
Per capita GNI indicates ...and ability of individuals to While efficacy requirements are high
country wealth... purchase a vaccine across countries
45 100
# of Americas
countries Europe % of • Efficacy hurdles for private
40 90
E. Mediterranean pop. market uptake likely to be higher
SE Asia able(1) to 80 than for public market
35 Africa purchase
$10
30 vaccine
70 • Majority of private market likely
to opt for alternative prevention
60
25 over an expensive, low efficacy
vaccine
50
20
40 • Wealthiest segment may
15 purchase all available
30 interventions
10 -even expensive ones, such
20 as residual spraying
5 10 20 18
0
7 7
0
0-0.5 0.5-1 1-2 2-3 3-4 >4
na
a
ia
l
ga
di
er
ha
GNI per capita ($ K) In

ne
g
G
Ni
Se
1) Able to purchase vaccine defined as 2 weeks of annual income, based on country per capita levels and income distribution
INDIVIDUAL ATTITUDES FURTHER LIMIT PRIVATE
MARKET OPPORTUNITY EVERYWHERE EXCEPT INDIA
In Brazil, Thailand, Africa, cultural expectation ...Whereas in India, private market is
is to obtain health services from government... increasing
In primary research countries, standard Emergence of urban malaria means higher
vaccines are provided free of charge by the socio-economic class is seeking private
government prevention and treatment for malaria
• Similarly, malaria-related interventions are
often also government-funded Large proportion of health care in India
provided by private sector
In countries with a socialist history, private • Vaccines often obtained via private sector
market for health services is relatively new
• Paying for health services, or paying more Government health care infrastructure
for better service, has not been completely considered poor quality and inefficient
absorbed into the culture
Indian middle and upper socio-economic
For Brazil and Thailand, private health strata (SEC A & B) primarily accesses health
services are more common in higher-income care from private sector
areas; however, income levels in malaria - accounts for ~ 200 - 250 Mn people
endemic regions very low - annual birth cohort of ~ 5.5 – 6.5 MM
• Rely heavily on health services provided
by government
• Unlikely to be able to afford high-cost
vaccines
Significant
Significant uptake
uptake of
of vaccine
vaccine in
in private
private market
market likely
likely in
in India
India ifif efficacy
efficacy hurdles
hurdles can
can be
be met
met
KEY TAKEAWAYS
Private Market
Product profile varies from public market requirement

• Higher efficacy threshold given availability of alternatives (minimum 50%)
• Administration restrictions lower due to routine doctor visits
• Cost less sensitive than for public market
Access and wealth constraints limit private market to subset of populations

• Wealthiest segment of population likely to purchase all relevant
interventions
- i.e. residual spraying along with ITNs, a vaccine, and ACT purchases
• Only small fraction of remaining population can afford typical vaccine costs
and this group will likely have to decide among interventions
- i.e. only 0.03% of Nigeria privately purchases $12 Hep B vaccines
• However, small fraction of large country is still a substantial population
(~600,000 Indian citizens purchase Hep B)
• Proximity to clinics and regulations on private sales of vaccines also limit
demand
- many countries have <300 clinics able to administer a private vaccine
Cultural expectation of publicly-provided health services translates to some

individuals not seeking private vaccination, even if they can afford it
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
TRAVELERS MARKET HAS EXTREMELY HIGH
PRODUCT REQUIREMENTS
PUBLIC
PUBLIC • Population of • Product profile • Coverage of • Decision
MARKET
MARKET endemic target pop. making and
adoption KOLs
PRIVATE
PRIVATE • Population of • Product profile • Private clinic • Individual
MARKET
MARKET endemic access attitudes

TRAVELERS
TRAVELERS endemic before traveling vs. prophylaxis
countries

MILITARY
MILITARY militaries deployed vs.
none
~147 MM TRAVELERS TRAVEL TO MALARIA ENDEMIC REGIONS
22MM of These Are At-Risk For Malaria
International tourist arrivals Percent of travelers at-risk(1) Travelers affected in malaria
2002 within endemic countries endemic countries
100
(MM) (%) 100 MM)10
80 80 8
68
60 60 6
9.9
41
40 40 4
35 7.5
100
20 20 2
2.9
13
1.0
0 3 7 0.5
0 3 0
Am ericas Europe Asia Brazil China Asia South Africa America Africa Asia Europe Middle
Origin of Traveler America East
Endemic destination
Destination Destination
Africa Not at risk
Middle east
Europe
Americas
At risk
Asia
(1)Countries clustered depending on traveler mobility within country (rural areas, jungle/bush, provinces with high indices of malaria)
Note: Malaria endemic countries defined by WHO, ‘developed world’ refers to travel from the Americas (South, Central, Caribbean, North America),
Europe (Northern, Western Central/Eastern, Southern, East Mediterranean Europe) and Asia (North-East Asia, South-East Asia, Oceania, South Asia)
as defined by WTO. It is important to note that not all travelers to malaria endemic countries will be traveling to regions with high malaria incidence within them.
Source: World Tourism Organization “World Overview and Tourism Topics” 2003 edition
INTERNATIONAL TOURISM TO ENDEMIC REGIONS PROJECTED
TO INCREASE OVER THE NEXT 15 YEARS
Projected arrival forecast from developed world to high-risk areas of

malaria endemic countries by destination region
(M) 70
Trips
60 1.3
1.7
50
29.9
40
0.7 CAGR
1.3
30
M. East 5.2%
14.8
0.5
1.0 Europe 3.3%
20
19.9
9.9 Asia 6.3%
12.1
10 Africa 5.6%
7.5
4.9 7.2 Americas 5.1%
2.9
0
2002 2010 2020
Year
Note: Malaria endemic countries defined by WHO, ‘developed world’ refers to travel from the Americas (South, Central, Caribbean, North America),
Europe (Northern, Western Central/Eastern, Southern, East Mediterranean Europe) and Asia (North-East Asia, South-East Asia, Oceania, South Asia)
as defined by WTO.
Source: World Tourism Organization “World Overview and Tourism Topics” 2003 edition; BCG analysis
MALARIA CASES AMONG U.S. TRAVELERS ARE DECREASING
BUT INCIDENCE OF FALCIPARUM STRAIN IS INCREASING
Number of malaria cases Percentage of cases by

reported by US travelers plasmodium species
Number 1,500 (%) 100
of cases 1402 1383 11 13 Species
1337 16
Undetermined
80
Mixed
1,000 25
37 28 P.Ovale
60
P. Malariae
P. Vivax
40
500 P. Falciparum
50 52
20 44
0 0
2000 2001 2002 2000 2001 2002
Note: Malaria cases confirmed by blood film are reported to local and state health departments by health-care providers or laboratory staff; number of cases
probably underreported; “Imported malaria” refers to malaria acquired outside the U.S. and its territories
Source: CDC Malaria Surveillance Report 2002
GENERAL MALARIA PROTECTION IS HIGH AMONG TRAVELERS TO
ENDEMIC REGIONS BUT MANY DO NOT TAKE CHEMOPROPHYLAXIS
Traveler general malaria

prevention measures(1) Traveler chemoprophylaxis use(2)
(%) 100 (%) 100
Origin of Traveler
78 U.S.
80 80
Europe
Asia
60 60
46 44
93 90
40 83 40 36
68
58 26
55
20 20
3
0 0
Clothing Repellent Doors Insecticide Mosquito Air High-risk malaria Low-risk malaria
Closed net Conditioner endemic regions endemic regions
(Travel destination)
(1) Journal of Travel Medicine, Volume 11, Issue 01, 2004, January “Travelers’ Knowledge, Attitude and Practices on the Prevention of Infectious Diseases”. Interviews conducted in Johannesburg
Airport, Inclusion Criteria: European residents on intercontinental flights. High-risk malaria destinations were tropical Africa, Papua New Guinea and the Solomon Islands with regional and seasonal
exceptions. Low-risk malaria regions were endemic regions in Latin America, Asia and Southern Africa. 219 malaria and 200 vaccine preventable questionnaires were available for analysis.
(2)Journal of Travel Medicine, “Travel Health Knowledge, Attitudes and Practices among U.S. travelers” 404 respondents, interviews conducted in JFK airport among travelers going to target destination
country identified as high risk. High risk countries for malaria were Ghana, Nigeria, Liberia, Tanzania and Kenya. Low-risk were: rural areas with known risk of malaria such as Brazil, Ecuador, DR,
China, The Philippines, Thailand, Guyana and El Salvador. “Travelers Knowledge, Attitudes and Practices on Prevention of Infectious Diseases: Results from a Pilot Study” 609 responses from
European travelers boarding flights to developing countries (Africa, Asia, excluding Japan and Singapore, and Latin America) “ “Travel Health Knowledge, Attitudes, and Practices among
Australasian travelers” 21011 surveys conducted at five airports in Australasia, distributed to passengers from flights to countries in Asia, Africa, and South America. High risk malaria areas were all
rural/jungle areas in Asian Countries except for Northern China, Singapore, Taiwan and Japan and all Sub-Saharan countries.
TIMING OF IMMUNIZATION AND DURATION OF TIME IN
COUNTRY IS CRITICAL FOR A POTENTIAL MALARIA VACCINE
Only 30-50% of travelers plan at least 4-8 weeks

Most travelers remain in destination < 2 weeks
in advance
Pre-travel planning period Duration of trip

(%) 100 (%) 100
Origin of Origin of
Traveler Traveler
U.S. U.S.
80 80
Europe Europe
Asia Asia
60 60
40 40
20 20
0 0
<1 week 1-2 weeks 2-4 weeks 4-8 weeks < 2 weeks 2-4 weeks > 4 weeks
Number of weeks in advance of trip
Depending
Depending on
on profile,
profile, vaccine
vaccine most
most useful
useful for
for travelers
travelers who
who plan
plan in
in advance
advance and/or
and/or take
take long
long trips
trips
Source: Graph I and II from combined studies (U.S., Europe, and Australasia traveler) Journal of Travel Medicine “Travel Health Knowledge, Attitudes and Practices
among U.S. travelers”, “Travelers Knowledge, Attitudes and Practices on Prevention of Infectious Diseases”, “Travel Health Knowledge, Attitudes
and Practices among Australasian travelers”
ALTHOUGH TRAVELERS THINK HIGHLY OF VACCINES, FEW
USE THEM TO PROTECT AGAINST INFECTIOUS DISEASES
Vaccine opinion rate high
...but Hep A uptake is low Variety of reasons drive low uptake
among travelers ...
Percent of travelers who believe Vaccine uptake among Reasons travelers
vaccines are important travelers(1) refused vaccination
% of100 % of 100 % of 100
travelers travelers travelers
80
80 80
80 74 76
60
60
60 40
25
40 37 20
10
40 4
0
20 14
10 Not at risk Disliked Vaccines
20 5 535 vaccines are not
22 22
important
0
Europe U.S. Asia Vaccine concerns included:
0 • Side effects
U.S. Europe Asia Hep A Typhoid • Cost
Origin of traveler Hep B Diphtheria • Pain
Influenza Yellow Fever • Belief that they are useless
(1) Vaccine uptake information not available for all countries

Note: Hep A protection surveyed among travelers at risk of contracting the disease in country of destination, study methodologies in backup slides
Source: Journal of Travel Medicine: Volume 11, issue 01, 2004, “Travel Health Knowledge, Attitudes, and Practices among U.S. travelers”; Volume 10, Issue 02, 2003, “Travelers
Knowledge, Attitudes and Practices on Prevention of Infectious Diseases”; Volume 11, issue 01, “Travel Health Knowledge, Attitudes and Practices among Australasian
travelers”
TRAVELER VACCINE UPTAKE DEPENDS ON ITS PROFILE
Impact on
Attribute demand Details Comments
• Would need to be at least as efficacious as prophylaxis (98%) “From a public health

perspective, there is very
• Potential risk of misuse of standby treatment with lower efficacy
Efficacy High
High low tolerance for risk with
• Previous low efficacy vaccine (cholera) had low uptake travelers”- CDC
“A 30% efficacy vaccine

is too low. It would be a
• Short nature of “average trip” decreases importance of long
Duration Low hard sell”- Canadian KOL
Low duration vaccine
“Cholera vaccine has
been highly ineffective”-
CDC
• Price sensitivity may depend on health-care system and drug
Cost Medium
Medium coverage in home country “Cost of treatment is a
• Cost relative to chemo-prophylaxis will likely drive demand hurdle for a lot of
people”- CDC
• Travelers seem less price-sensitive if side effects of chemo-
prophylaxis could be avoided
• Falciparum primary requirement for travelers
Species Medium
Medium • However, lack of vivax efficacy could hurt vaccine credibility or
generate negative impressions
“There is a general public

• Time required between administration and departure will be key dislike to taking tablets-
Administration High
High driver in vaccine usefulness given wide variation in planning U.K.” KOL
habits observed
“People are still afraid of
needles”- KOL
• Increasing population that seek pre-travel medical advice could
Education High
High heavily influence number that can receive vaccine
• Traveler attitudes towards vaccines vs. tablets also important

KEY TAKEAWAYS
Travelers Market
Frequency of international travel to high-risk malaria areas is growing
• 22 MM arrivals in 2002 and 60 MM projected in 2020
Traveler behavior varies significantly in chemoprophylaxis use, pre-travel planning habits,

duration of trips, and attitudes toward vaccines
• 78% of European travelers to high-risk malaria areas take prophylaxis vs. 46% of
American travelers to high-risk malaria areas take prophylaxis
- however, in low risk areas, prophylaxis use by Europeans lower than by Americans
• 30-50% of travelers plan trips 4-8 weeks in advance
• > 50% of travelers spend less than 2 weeks in destination region
Key demand drivers are efficacy, timing of immunization, education, duration of trip
• Vaccine must be as effective as available prophylaxis (~98%)
• Vaccine most useful if effective within a month of travel due to travel planning habits
• Market likely limited by number of people who seek pre-travel health advice from a
physician
• Vaccine most useful for people who remain in destination for long periods of time (over
1 month)
Ultimate demand will depend on product profile trade-offs with available prophylaxis options
MILITARY MARKET ALSO HAS SPECIFIC
PRODUCT REQUIREMENTS
Public
Public • Population of • Product profile • Coverage of • Decision
market
market endemic target pop. making and
adoption KOLs
Private
Private • Population of • Product profile • Private clinic • Individual
market
market endemic access attitudes

Travelers
Travelers endemic before traveling vs. prophylaxis
countries

Military
Military militaries deployed vs.
none
OVER 18 MM PEOPLE SERVE IN MILITARIES WORLDWIDE
US Leads In Military Spending
Militaries size and total expenditure

3,000
Total # of active
troops
China
(K) 2,500
2,000
1,500 US
India
Russia
1,000
S. Korea
500
Thailand Taiwan Germany France
Indonesia Japan
Ukraine Poland Spain Italy Saudi Arabia
UK
Croatia Israel
Portugal Greece UAE
Netherlands
Sweden
Libya Czech Canada Australia
0
0 50,000 100,000 150,000 200,000 250,000 300,000
$ / Active Person
Note: Includes only militaries with over 50,000 active members and over $10,000 / member
Source: US Dept. of Defense, IISS “Military Balance,” World Military Expenditures and Arms Transfers” Bureau of Arms Control, Center for Disease Information
TROOPS ARE CONTINUALLY DEPLOYED TO
MALARIA-ENDEMIC REGIONS
US military deployments (1990-2004) UK military deployments (1997-2002)

# of active troops # of active troops
1,750,000 250,000
Average % endemic: 6% Average % endemic: 2%
1,500,000
200,000
1,250,000
150,000
1,000,000
750,000
100,000
500,000
50,000
250,000
0 0
1990 1992 1994 1996 1998 2000 2002 2004 1997 1998 1999 2000 2001 2002
Year Year
Average length of deployment 110 days Average length of deployment 180 days
Malaria-endemic
Non-malaria endemic
•• Of
Of US
US troops
troops deploying
deploying to
to non-US
non-US locations
locations from
from 1990-2004,
1990-2004, 26%
26% were
were sent
sent to
to malaria
malaria endemic
endemic regions
regions
•• %
% of
of troops
troops exposed
exposed toto malaria
malaria endemic
endemic regions
regions higher
higher due
due to
to deployment
deployment cycles
cycles
Note: Malaria endemic defined as a country or region with any malaria.
Source: DASA, US DOD, Heritage, Malaria Foundation International; BCG interviews
MILITARIES FOCUS ON READINESS AND PREVENTING ILLNESS
Malaria Vaccine Has Potential To Maximize Both
“Once military personnel is “The military’s main concern and

sick, they are useless for a what a vaccine would be mainly
mission” -WRAIR used for is to prevent illness” -KOL
“Focus is to prevent
malaria, full-stop” –
British Forces “Soldiers need to be
prepared to be deployed
anywhere, if need be” –
WRAIR
“Troops becoming unwell will “Malaria control is seen as a

affect operational fundamental performance metric
capabilities...this is of battalion commanders”
unacceptable” –British Forces - Indian Army

ILLNESS IS A SERIOUS ISSUE FOR MILITARIES
More Soldiers Die From Diseases Than from Wounds and Injuries
US Army hospital admissions during war

100%
90%
80%
70%
60%
50% Diseases
Injuries
40%
Wounds
30%
20%
10%
0%
WWII Korea Vietnam Persian Gulf
In
In Somalia
Somalia and
and Operation
Operation Restore
Restore Hope,
Hope, malaria
malaria was
was the
the No.
No. 11 cause
cause of
of casualties
casualties
Source: NIC (2000)
CURRENT TACTICS FOCUS ON PREVENTION, BUT COMPLIANCE
ISSUES MEAN THAT MALARIA IS STILL A CONCERN
Three key preventative actions in US military US military malaria incidence (2000-2003)

100
1 Personal Prevention
• DEET 90 Unknown
Troops
• Uniform repellant SE Asia 84
80 Africa
• Protective clothing
C/S America
70 Korea
2 Chemoprophylaxis Central Asia
• Choloroquine 60 57
55
• Mefloquine 52
50
• Doxycycline
• Primaquine 40
30
3 Unit Protection
• Bulk repellant 20
• Camp selection
10
• Mosquito surveys
• Insecticides 0
• Early diagnosis 2000 2001 2002 2003
Compliance
Compliance drops
drops largely
largely due
due to
to long
long deployment
deployment times
times
-- US
US deployments
deployments average
average 110
110 days,
days, UK
UK deployments
deployments average
average 180
180 days
days
Source: Dept. of Defense, Virtual Naval Hospital
MILITARIES ACTIVELY VACCINATE THEIR TROOPS
Troops deploying to
All troops receive
high risk areas receive
United States United Kingdom United States United Kingdom
Influenza Meningococcal C Yellow Fever Meningococcal A

Measles Polio Typhoid Japanese Encephalitis
Meningococcal Tetanus Japanese Encephalitis Rabies
(A,C,Y,W-135) Diphtheria Encephalitis (tick)
Mumps Yellow Fever Occupational Risk:
Polio Hepatitis A Hepatitis B Occupational Risk:
Rubella Typhoid Plague Hepatitis B
Tetanus TB Rabies Rubella
Diptheria Varicella
Hepatitis A Small Pox
Anthrax
“The military currently gives Hep A vaccine to all “Soldiers deployed to Korea had to take the anthrax
its soldiers. They made major purchases in recent vaccine, those travelling to Kuwait took the small
years and the only reason they did so was pox vaccine, those going to Kenya received the
because Hep A was a major problem in North yellow fever vaccine and some going to Asia
Africa during World War II” –KOL received the JE vaccine” -WRAIR
Comfort
Comfort with
with vaccination
vaccination as
as aa prevention
prevention technique
technique could
could drive
drive demand
demand for
for aa potential
potential malaria
malaria vaccine
vaccine
•• “The
“The most
most efficient,
efficient, cost-effective
cost-effective and
and easiest
easiest way
way to
to prevent
prevent any
any infectious
infectious disease
disease is
is with
with aa
vaccine”
vaccine” –Naval
–Naval Medical
Medical Research
Research Institute
Institute
Source: Interviews, Institute of Medicine of the Natural Sciences, Naval Medical Research Institute
MILITARY DEMAND HINGES ON VACCINE PROFILE
Unique Set of Challenges For Military Markets
Attribute Impact on Demand Details Comments
• Efficacy against clinical disease most “A malaria vaccine
important needs to be very
Efficacy High
High
- 50-80% threshold mentioned effective for troops in
the field” -KOL
• Duration will drive whether some or all “It needs to be highly

Duration Medium troops receive a vaccine effective for 4-6 months
Medium
- 4-6 month minimum mentioned at least” -WRAIR
• Cost not an issue for high expenditure “Price/cost of the vaccine is not
Split
Split forces an important issue” -WRAIR
Cost
High/Low
High/Low • Cost an issue for lower budget forces
“A large section would have to be
• Military cannot afford to have anyone inoculated...this is unlikely to be
sick cost effective”- Indian army
Species Low
Low
- species of disease not important
- military affected by all species
• 6 month window to reach recruits

Administration Medium
Medium
• 1 month window to reach deploying
troops
• Safety a big issue; must not hinder “Safety is a huge

Safety High
High ability to train or fight
issue” -WRAIR
KEY TAKEAWAYS
Military Market
Preparedness is essential to maintaining an alert force

• Malaria incidence is problematic for militaries
- largely due to low chemoprophylaxis compliance from extended
deployments
Vaccine used regularly as preventative tool
Demand will hinge on vaccine characteristics

• Safety is key
- troops must be able to train and fight without side effects or risks
• Militaries will immunize segments of personnel based on vaccine profile
- All troops vs. troops deploying to high-risk areas
• Efficacy against clinical disease is critical
- militaries cannot afford illness; “a sick soldier is a useless soldier”
- vaccine must compete with prophylaxis compliance levels (50-80%)
• Cost not an issue for militaries with high expenditures (i.e. US, UK, Japan), but
may significantly affect demand from militaries with smaller budgets
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
MALARIA VACCINE DEMAND MODEL NEEDS TO BE FLEXIBLE
AND TRANSPARENT DESPITE INHERENT COMPLEXITY
Key
Key model
model attributes
attributes
Base demand estimate logic on well-established and reliable

data and reasonable assumptions
Realistic
Build user-friendly, logical model without a “black box”

Transparent component
Allow MVI to improve quality of estimates through future

Flexible research and model adaptation
Generate actual demand forecast ranges and sensitivities that

Concrete are as accurate as possible given current data availability
MODEL FOLLOWS THE DEMAND LEAKAGE FRAMEWORK
FOR ASSESSING MARKET POTENTIAL
A Need B Product C Access D Attitude
# of
doses
Public: Which countries? Target population Vaccinate none How many

How does product
coverage / donor versus high risk doses of
profile influence? vaccine in
funding available? versus infants
versus children a given
versus all? year does
this
Private: Which individuals? How does product Private clinics/ Use private market translate
ability to pay? for vaccine? into?
profile influence?
Travelers: Which travelers? Individuals seek Prefer nothing

How does product
pre-travel advice? versus chemo-
profile influence? prophylaxis or
vaccines?
Military: Which militaries? How does product Military budget Vaccinate none
profile influence? sufficient? versus all versus
deployed only?
DEMAND MODEL USES SCENARIO DRIVERS, DATA INPUTS,
AND ATTITUDINAL ALGORITHMS TO FORECAST DEMAND
Sample Information Flow – Does Not Represent Full Scope of Model
Scenario
Scenario drivers
drivers Model
Model logic
logic Modular
Modular outputs
outputs
Demand over time

Data Attitudinal Attitudinal
Efficacy inputs inputs algorithms
2010 2011 2025
Age, birth Include
cohort country X
if efficacy > Demand by geography
Duration
Y
GDP, income S
Africa SE Asia
America
Cost
Include
military Demand by population
Malaria if duration >
incidence Z Traveler
Funding Public Private
Military
Model
Model has
has flexibility
flexibility to
to accommodate
accommodate changes
changes in
in vaccine
vaccine landscape
landscape and
and
country
country characteristics
characteristics over
over time
time
INPUTS AND ALGORITHMS BASED ON FINDINGS
FROM PRIMARY AND SECONDARY RESEARCH
Including Extensive Interviews In Eight Endemic Countries
Data inputs based on Attitudinal inputs incorporate

primary and secondary sources learnings from country research
Secondary data from sources such as: Sample algorithms include:
• WHO/RBM • Product profile threshold to introduce vaccine
• World Bank • Use of vaccine vs. other components of
• UN intervention portfolio
• Global Fund • Attitude of government and donors with
• OECD respect to demographic and regional
• Journal of Travel Medicine targeting of vaccine
• US Department of Defense • Funding scenarios for the vaccine
• Military criteria for vaccinating all troops vs.
Primary data from interviews deployed troops only
• Data sourced from reports and books • Travelers choice of chemo-prophylaxis or
published by in-country interviewees vaccine
Complete
Complete list
list of
of sources
sources included
included in
in appendix
appendix
PRIMARY RESEARCH FINDINGS WERE EXTRAPOLATED TO ALL
ENDEMIC COUNTRIES VIA CLUSTERING METHODOLOGY
Clustering
Clustering methodology
methodology Application
Application in
in model
model
Model minimizes the need to
Country segmentation and Country mapping
selection for research cluster to increase accuracy
• Majority of model inputs are
objective and specific to
countries
Countries
• Few inputs based on cluster
selected
for extrapolation
research
Single research
Universe
country data can
Country specific inputs include:
of be extrapolated to • Population size
malaria cluster • GDP/income data
afflicted
countries
• Health care infrastructure
• Access and coverage data
Other
countries Cluster specific inputs include:
• Product profile levels at
which vaccine likely to be
accepted
Based on need Based on Combination of • Attitude of governments with
and similarity of research country
data can be
respect to segment of
access/attitude malaria related extrapolated to population covered (e.g.,
characteristics cluster infants vs. high risk areas)
• Segments likely to have
access to private market
FOUR KEY MODULES IN THE MODEL PROJECT DEMAND FOR
PUBLIC, PRIVATE, MILITARY AND TRAVELERS MARKETS
Medical Govt funds
Total population, Rate of increase
coverage of Groups likely available for
Public Area birth cohort, Groups of new vaccine
target population vaccinated for malaria, cost-
market of country at risk children under 5, likely (based on
(e.g., projected select countries vaccinated effectiveness
pregnant women analogs)
EPI) overall
Donor funds
Dosage
available for
schedule and Compliance
malaria, cost- Number boosters factor Number of
effectiveness vaccinated doses
required
Citizens of Income Access to private Individuals likely

Private Pop. Access to to purchase
malaria-endemic distribution of market for select
market likely to private vaccinate
countries countries countries market
afford
vaccine overall
World Dosage
population schedule and Compliance
Number boosters factor Number of
vaccinated required doses
Percent deployed
Vaccinate all to malaria- Percent Deployment cycle
All active military Dollars spent per
Military troops vs. at-risk endemic regions deployed length / annual
personnel to malaria active member
deployed troops for select turnover
countries regions
Legend: overall
Scenario drivers – for
given product profile, e.g.,
Dosage
Efficacy Duration Cost Number likely schedule and Compliance
Militaries Number
vaccinated for boosters factor Number of
that can likely
Data input- select countries required doses
afford vaccinated
from secondary sources
vaccine overall
Attitudinal inputs -
from primary Fraction who
research, based on Travelers to Travelers to high- Fraction of
Travelers seek pre-travel
given product profile Travelers endemic risk areas within travelers likely to
to high risk advice, take
countries select countries areas get vaccine
prophylaxis
Algorithm applied this step overall
Dosage
Number boosters factor Number of
Result of
formula vaccinated required doses
DETAILED INFORMATION FLOW OF PUBLIC MARKET MODULE
Population Medical
distribution: coverage of Acceptance of
Area
World Public Birth cohort, target vaccine based
of country
population market children < 5, population on profile
at risk
pregnant (e.g., projected
women, etc. EPI)
Legend: Groups likely Rate of increase

Scenario drivers – for vaccinated for Pop. of new vaccine
given product profile, select countries likely (based on
e.g., vaccinated analogs)
Effic. Durn. Cost overall
Data input-
from secondary Govt funds Donor funds
sources
available for available for
malaria, cost- malaria, cost-
Attitudinal Number
inputs effectiveness effectiveness vaccinated
from primary
research
Algorithm applied this step
Dosage
boosters factor Number of
required doses
Result of
formula
METHODOLOGY TO GENERATE UPTAKE
SCENARIOS FOR EACH COUNTRY
Define upper Run scenarios
Define rate Run scenarios
threshold for around upper
of uptake around uptake
coverage threshold
• For each country • Based on progress in • Based on historic EPI • Based on vaccine
individually economic and health data analogues
care indicators
• Based on historic EPI • Baseline defined as - e.g. baseline: DPT3
data • Using regression uptake of DPT3 average for region,
analysis, e.g. EPI average for region fast: HepB average
- for different vaccine
coverage as influenced where implemented
coverage, e.g. DPT3
by GDP/cap
as base-line coverage, • Based on scenarios
HepB as high • Using specific around funding
coverage where scenarios availability,
implemented, others sustainability planning,
etc.
100% 100% Sc. 2: 90% 100% Base-line 100%
80%
uptake
E.g. ~ 80% 80% Sc. 1: 70% 80%
based on
80%
60% in Ghana 60% 60% historic 60%
40% 40% 40% DPT3 40%
20% 20% 20% 20%
DPT3
0% 0% 0% 0%
0 n years 0 n years 0 n years 0 n years
INPUTS TO MODEL
Scenario drivers Data inputs (i) Data inputs (ii) Attitudinal algorithms
• Efficacy against • Population by country • Active military troops • Product profile

clinical and severe • Population at risk per country required for entry in
disease • Projected birth cohort • % deployed to malaria- public market
• Duration of action • Projected children < 5 endemic regions • Government view of
• Cost per dose • Historical vaccine • Deployment length which populations to
• Doses required uptake by country per • Average annual vaccinate
• Boosters required vaccine turnover - Age-groups
• Plasmodium target • Projected EPI coverage • Budget per soldier - Regions / states
- P. falciparum • Projected peak • Travelers to developed • Product profile
- P. vivax coverage and rate of world from developing required in private
• Population increase of coverage • Percent who seek pre- market
- Infants for vaccines travel advice • Attitude toward
- Children < 5 • Compliance estimates • Advance window for vaccination in private
- Pregnant women • GNI, per capita and seeking advice market
- HIV positive house-hold income • Percent who take • Product profile
• Donor funding distributions chemo-prophylaxis required in military
• Timing of vaccine • Physicians / capita • Length of trip market
licensure • Urban vs. rural • Product uptake curves • Militaries’ likelihood to
- By age-group • Malaria burden per in private, military and vaccinate troops
- For pregnant country travelers markets • Product profile
women - Incidence required in travelers
• Post-licensure lag in - Deaths market
uptake - Others • Fraction of travelers
- Due to regulatory likely to get vaccine
and policy
development
requirements
MODEL ALLOWS US TO RUN SCENARIOS AND
SENSITIVITIES AROUND PREDICTED DEMAND
Also Creates Flexible Tool That Can Be Updated Over Time
400
Scenario 1
A flexible and adaptable tool
350
300
250
200
150
100
50
Model uses base case to incorporate primary 0

'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
research findings and predict demand Scenario 2

• Inputs are variable and inter-relationships 400
350
300
have been built across variables

250
200
150
100
50
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
Therefore, can develop and test complex 350

Scenario Comparison
scenarios around:
300
250
• Product profile
200
150
• Country-specific inputs
100
50
• Attitudes
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
• Other Sensitivity Analysis
20
-10
18
-6
Can also conduct sensitivity analyses around -5

5
any single variable by changing it

3
-3
1
-1
incrementally vs. other variables -25 -15 -5 5 15 25
SUMMARY OF MODEL METHODOLOGY
Model needs to be flexible and transparent despite inherent complexity

• Needs to be realistic, transparent, flexible and concrete
Model follows the demand leakage framework for assessing market potential
• Need, Product, Access and Attitude
Demand model uses scenario drivers, data inputs, and attitudinal algorithms to forecast
demand
Inputs and algorithms based on findings from primary and secondary research
• Including extensive interviews in eight endemic countries
Primary research was used to understand impact of demand drivers related to attitudes of
key stakeholders where secondary data was unavailable
• Findings from primary research extrapolated to all endemic countries via
clustering methodology
Four key modules in the model project demand for public, private, military and travelers
markets
Model allows us to run scenarios and calculate sensitivities around predicted demand
• Creates flexible tool that can be updated over time
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market

• Public market
• Private market
• Travelers market
• Military market
Appendix
PUBLIC MARKET DEMAND SCENARIOS
Base Case
Sensitivity
Efficacy
Time of Introduction
Market Uptake
Cost
BASE CASE DEFINITIONS FOR THE PUBLIC MARKET
Base case definition
• Strain of vaccine: Falciparum

Product profile
• Efficacy of vaccine: 50% against clinical and 50% against severe disease
of vaccine
• Age-groups: Protection at all age-groups except in pregnancy
• Duration of action: > 1 year
• Dosage: Three doses followed by annual booster
• Cost: US$ 7 / dose and US$ 5 incremental delivery cost per course; similar pricing
in all malaria afflicted countries
• Donor organizations support malaria programs at current level, ~ US$ 300 Mn /

year
Funding
• Funding of vaccine based on cost-effectiveness trade-offs with existing
availability
interventions
•30% of malaria dedicated funds used to provide vaccines
•10% of immunization funds used to provide a malaria vaccine
• Future growth of funds at donor country GDP growth
• Priority given to countries with highest need
• Vaccine registered for children < 5 years in 2010, for children > 5 in 2011 and in
Timing of
adults in 2012
introduction
• Post-licensure lag 5 years in Africa, 3 – 4 years ROW
Uptake in • Maximum coverage based on EPI performance on DPT projected into the future
markets • Change in coverage based on past experience with new vaccine introduction
Source: BCG analysis

PUBLIC MARKET FOR A MALARIA VACCINE
IN 2025 LIKELY TO BE ~70 MM PEOPLE
For a 50% Efficacious Vaccine, Unconstrained by Funding
Estimated vaccine demand with no
funding constraints (2010-2025) Key messages
# of people Due to post-licensure

120
(MM) introduction lag, uptake
114 MM
only begins 5 years
100
doses after vaccine approval
Children < 5
80
Children > 5 Majority of demand
60
Adults except from Africa due to lower
40
in pregnancy efficacy levels of
vaccine
20
0 Demand estimate
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 assumes sufficient
funding is available to
S & SEA Eastern Europe Vaccine approval fund all doses that can
Southern Africa Eastern be delivered
East Africa Mediterranean
W&C Africa Americas

LEADING TO A MARKET SIZE IN 2025 OF 114 MM DOSES
For a 50% Efficacious Vaccine, Unconstrained by Funding
Estimated vaccine demand with no

funding constraints - Doses (2010-2025) Key messages
# of doses Conversion of number

120
(MM) of vaccinated people to
114 MM
doses depends on
100 • Age profile of
Children < 5
80
populations
Children > 5 • Boosters required by
60
Adults except vaccine
40
in pregnancy • Compliance rate
20
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
S & SEA Eastern Europe Vaccine approval

Southern Africa Eastern
W&C Africa Americas

HOWEVER, ONLY 35% OF FULL POTENTIAL DEMAND IS LIKELY
TO BE FUNDED AT CURRENT DONOR ACTIVITY LEVELS
Comparison between full potential demand and funds likely to be available (2025)
# of 100
people US$ 650 MM
90
(MM) additional
80 donor funds
71 7 required
70 17
S & SEA
60 Southern Africa
50 East Africa
W&C Africa
40 Eastern Europe
47 Eastern
30
Mediterranean
20 Americas
10 Donor funded
Gap between full
0 potential and
Full potential Expected Expected Funding gap funded doses
demand from Country Donor funded
countries funded doses doses
Donor
Donor activity
activity at
at the
the current
current level
level insufficient
insufficient to
to fund
fund full
full potential
potential demand,
demand,
47
47 MM
MM additional
additional people
people could
could be
be protected
protected with
with full
full funding
funding
Note: Assuming current levels of donor activity in the future
FUNDING GAP INCREASES OVER TIME FROM 1 MM
PEOPLE IN 2019 TO 47 MM PEOPLE IN 2025
Vaccine demand likely to be funded at
current donor activity levels (2010-2025) Key messages
# of people (MM) Countries unable to

120
fully self-fund demand
100
• As majority of
demand for a 50%
Children < 5
80 efficacious vaccine is
Children > 5 from high burden,
60
Adults except low income countries
47
in pregnancy
40 34
24
10
16 Donor activity at current
20 1 4
levels insufficient to
0
vaccinate all people
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 who could be reached
Donor funded Country funded
doses doses Gap increases over time
Unfulfilled demand due to Vaccine approval as potential coverage
funding constraints increases faster than
ability to fund a vaccine
Base Case
Sensitivity
Efficacy
Market Uptake
Cost
DEMAND FOR A MALARIA VACCINE MOST SENSITIVE TO
EFFICACY AND UPTAKE SCENARIOS
For Demand Unconstrained By Funding Availability
Sensitivity of funding unconstrained demand to model inputs (MM of people IN 2025)
%
change
154 +117% Optimistic: 80%-clinical, 80%-severe

Efficacy 71 Base Case: 50%-clinical, 50%-severe
43 -39% Pessimistic: 30%-clinical, 50%-severe
122 +72% Optimistic: based on Hep B

Uptake scenario 71 Base Case: based on DPT-3
25 -65% Pessimistic: based on slow analogues
98 +38% Optimistic: 3 yr lag in Africa, 1--2 in ROW

Post-licensure lag 71 Base Case: 5 yr lag in Africa, 3–4 in ROW
47 -34% Pessimistic: 7 yr lag in Africa, 5–6 in ROW
81 +14% Optimistic: Suitable, approved in 2012

Use in pregnancy 71 Base Case: Not suitable
Pessimistic: N/A
Optimistic
Base case 0 50 100 150 200
Pessimistic # of people (MM in 2025)
Note: Sensitivity to demand drivers keeping all other variables constant at base-case levels; ROW: Rest Of the World
DEMAND FOR A MALARIA VACCINE MOST SENSITIVE
TO COST AND FUNDING GROWTH
At Current Funding Levels
Sensitivity of funded demand for 2025 to model inputs (MM of people)

%
change
62 +158% Optimistic: $4 / dose

Vaccine cost 24 Base Case: $7 / dose
18 -25% Pessimistic: $10 / dose
36 +50% Optimistic: doubles GDP growth

Funding Growth 24 Base Case: matches GDP growth
21 -13% Pessimistic: halves GDP growth
28 +17% Optimistic: 15% of funds

Vaccine funding 24 Base Case: 10% of funds
21 -13% Pessimistic: 5% of funds
26 +8% Optimistic: 35% of funds

Malaria funding 24 Base Case: 30% of funds
23 -4% Pessimistic: 25% of funds
25 +4% Optimistic: $4 / dose

Delivery cost 24 Base Case: $5 / dose
24 -1% Pessimistic: $6 / dose
Optimistic
Base case 0 10 20 30 40 50 60 70
Note: Sensitivity to demand drivers keeping all other variables constant at base-case levels
Base Case
Sensitivity
Efficacy
Market Uptake
Cost
DEMAND FOR AN 80% EFFICACIOUS VACCINE AS HIGH AS 154
MM PEOPLE IN 2025 WITH UNCONSTRAINED FUNDING
Funding unconstrained demand for varying
vaccine efficacy levels (2025) Key messages
Efficacy profile
Efficacy has a significant impact on vaccine
demand
80% clinical, • Funding unconstrained demand for
154
80% severe highest efficacy vaccine considered is
300% that of the lowest efficacy vaccine
considered
50% clinical, 60% of demand for a 50% efficacious vaccine
71
50% severe from Africa
• However, at 80% efficacy significant
uptake (63% of demand) outside of Africa
30% clinical, Uptake driven by a combination of factors
43
50% severe • Efficacy thresholds at which vaccine is
accepted in a country
- e.g., uptake in Thailand requires 80%
0 50 100 150 200 efficacy
# of people (MM) • Attitude of governments with respect to
population segments targeted, both
S & SEA Eastern Europe
demographic and geographic
Africa Eastern • Ability of country to reach target
Mediterranean population
Americas
76% OF DEMAND FOR AN 80% EFFICACIOUS VACCINE LIKELY
TO BE FUNDED IN 2025 AT CURRENT DONOR ACTIVITY LEVELS
Funded demand for varying vaccine efficacy
levels (2025) Key messages
Efficacy profile
Portion of donor and country funds
80% clinical, committed to a malaria vaccine increases at
86 31 37 154 higher efficacy levels
80% severe
• 50% of donor and country malaria funds
dedicated to a vaccine at 80% efficacy
7 • 30% of donor and country malaria funds
50% clinical, dedicated to a vaccine at 50% efficacy
17 47 71
50% severe
Higher efficacy results in a higher proportion
of full potential demand being funded
• 76% of funding unconstrained demand
5
fulfilled for 80% efficacy vaccine
30% clinical,
17 21 43 • 34% for a 50% efficacy vaccine
50% severe
Countries contribute towards a larger
proportion of funding at higher efficacy levels
0 50 100 150 200 • As richer countries, with lower malaria,
# of people (MM) burden are willing to take up vaccine
• However, ability of poorer countries to
fund vaccine is limited
doses doses
Unfulfilled demand due to
funding constraints
DEMAND FOR 80% EFFICACIOUS VACCINE IN ANY GIVEN YEAR
MORE THAN TWICE THAT FOR A 50% EFFICACIOUS VACCINE
Demand unconstrained by funding for varying efficacy levels - People (2010-2025)
# of people (MM)
200
Demand
150 for 80%
100
clinical,
80%
50 severe
vaccine
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of people (MM)
200 S & SEA
Demand Southern Africa
150 East Africa
for 50%
clinical, W&C Africa
100
50% Eastern Europe
50 severe Eastern
vaccine Mediterranean
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 Americas
# of people (MM)
200
Demand
150 for 30%
clinical,
100
50%
50 severe
vaccine
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
Base Case
Sensitivity
Efficacy
Market Uptake
Cost
REDUCING THE POST-LICENSURE LAG BY 2 YEARS COULD
LEAD TO 60 MM MORE PEOPLE BEING VACCINATED
For An 80% Efficacious Vaccine
Funding unconstrained demand for an 80% efficacious vaccine - People (2010-2025)
# of people
(MM)
300
Children < 5
250 Children > 5

Adults except
in pregnancy
200
1 – 3 year post-
150 licensure lag
60 MM
3 – 5 year post-
additional
licensure lag
100 people could be
vaccinated over
5 – 7 year post-
2 years
licensure lag
50
Vaccine approval
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25

Base Case
Sensitivity
Efficacy
Market Uptake
Cost
ADVOCACY AND IMPLEMENTATION SUPPORT FROM DONORS
COULD LEAD TO 140 MM MORE PEOPLE VACCINATED IN 2025
Demand for an 80% efficacious vaccine unconstrained by funding - People (2010-2025)
# of people (MM)
400
140 MM
300 add.
people
200
Unfulfilled
100 demand due to
funding gap
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 Additional uptake
assuming Hep B
coverage levels
Demand at current funding levels for an 80% efficacious vaccine – People (2010-2025) Uptake based on
# of people (MM) DPT coverage
400 levels
300 Additional funds from

increased coverage in
200 wealthy countries
100
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25

Base Case
Sensitivity
Efficacy
Market Uptake
Cost
FOR A US$ 2 / DOSE VACCINE, ALL OF DEMAND COULD BE
FUNDED AT CURRENT DONOR ACTIVITY LEVELS
Funded demand for varying cost

levels of a 50% efficacious vaccine (2025) Key messages
Vaccine cost Country Donor Countries and donors would consider adding
per dose funds funds a malaria vaccine to existing portfolio of
(US$ MM) interventions
US$ 2 25 46 145 272 Cost-effectiveness of the vaccine in
comparison to existing interventions affects:
• Willingness to fund vaccine
• Proportion of funds allocated to vaccine
US$ 7 7 17 47 101 237 Proportion of funds committed to a malaria
vaccine increases at lower cost levels
1 Results in a higher proportion of full potential
US$ 20 68 34 79 demand being fulfilled at lower cost,
assuming current funding levels
2
• 100% of potential demand fulfilled for a
US$ 2 / dose vaccine
0 20 40 60 80 100 # of
• Only 5% of potential demand fulfilled for a
people (MM) US$ 20 / dose vaccine
doses doses
Unfulfilled
demand
Note: All cost scenarios assume similar incremental vaccine delivery cost of US$ 5 / course, all US$ values refer to 2003 US$
Source: BCG Analysis
US$ 7 VACCINE CAN BE FULLY FUNDED TILL 2019, US$ 2
VACCINE CAN BE FULLY FUNDED THROUGHOUT
At Current Funding Levels
Funded demand for varying cost levels for a 50% efficacious vaccine - People (2010-2025)
# of people
(MM)
80
70
60
50
US$ 2 / dose
40
US$ 7 / dose
30
20 US$ 20 / dose
10
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
SUMMARY OF PUBLIC MARKET DEMAND
70 MM people could receive a 50% efficacious vaccine priced at US$ 7 / dose in 2025 if
sufficient funding is available
Base Case • However, only 35% of full potential demand is likely to be funded at current
donor activity levels
• Number of people unable to be vaccinated at current donor activity levels
increases from 1 MM people in 2019 to 47 MM people in 2025
Demand for an 80% efficacious vaccine as high as 154 MM people in 2025 with
unconstrained funding
Efficacy • 76% of demand for an 80% efficacious vaccine likely to be funded in 2025
• Demand for 80% efficacious vaccine in any given year more than twice that
for a 50% efficacious vaccine
Time of Reducing the time lag between approval of vaccine and implementation in country by 2
introduction years could lead to 60 MM more people being vaccinated, for an 80% efficacious vaccine
Advocacy and implementation support from donors could lead to 140 MM more people
Market vaccinated in 2025
uptake • By affecting fundamental access issues and improving government’s ability
to deliver vaccines
With a low cost vaccine, full potential demand for a 50% efficacious vaccine could be
fulfilled
Cost • US$ 7 vaccine can be fully funded till 2019, US$ 2 vaccine can be fully funded
throughout
Demand estimates most sensitive to efficacy, cost, funding growth and market uptake
Sensitivity rates
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market

• Public market
• Private market
• Military market
Appendix
PRIVATE MARKET DEMAND SCENARIOS
Base Case
Sensitivity
Efficacy
Affordability
Cost
BASE CASE DEFINITIONS FOR THE PRIVATE MARKET
Base case definition
• Strain of vaccine: Falciparum

Product profile
• Efficacy of vaccine: 50% against clinical and 50% against severe disease
of vaccine
• Age-groups: Protection at all age-groups except in pregnancy
• Duration of action: > 1 year
• Dosage: Three doses followed by annual booster
• Cost: US$ 15 / dose and US$ 5 delivery cost per course; similar pricing in all
malaria afflicted countries
Vaccine • Families are willing to spend upto 2 weeks of annual household income to
affordability vaccinate household members
• Vaccine registered for children < 5 years in 2010, for children > 5 in 2011 and in
Timing of adults in 2012
introduction • Post-licensure lag 2 years in Africa, 1 – 2 years ROW

1.4 MM PEOPLE LIKELY TO BUY A 50% EFFICACIOUS
VACCINE, 70% FROM AFRICA
Estimated vaccine demand by geography - People
(2010-2025) Key messages
# of people Post-licensure lag may
(MM) be shorter in private
2.5
market
2.0 • As Govt. vaccine
Children < 5
1.4 MM
adoption and funding
1.5
Children > 5 constraints typically
1.0 Adults except delay public market
in pregnancy uptake
0.5
Majority of demand
0.0 from Africa due to lower
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
efficacy levels of
vaccine
W&C Africa Americas

LEADING TO A MARKET SIZE IN 2025 OF 2.2 MM DOSES
For a 50% Efficacious Vaccine, Costing US$ 15 / dose
Estimated vaccine demand by geography - Doses

(2010-2025) Key messages
# of doses Conversion of number
(MM) of vaccinated people to
2.5
2.2 MM
doses depends on
2.0 • Age profile of
Children < 5
populations
1.5
Children > 5 • Boosters required by
1.0 Adults except vaccine
in pregnancy • Compliance rate
0.5
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25

W&C Africa Americas

Base Case
Sensitivity
Efficacy
Affordability
Cost
PRIVATE MARKET DEMAND FOR A MALARIA VACCINE
MOST SENSITIVE TO EFFICACY
Sensitivity of private market demand for 2025 to model inputs (MM of people)
%
change
17.4 +1150% Optimistic: 80%-clinical, 80%-severe

Efficacy 1.4 Base Case: 50%-clinical, 50%-severe
0 -100% Pessimistic: 30%-clinical, 50%-severe
1.9 +36% Optimistic: 3 weeks annual income

Affordability 1.4 Base Case: 2 weeks annual income
1.05 -25% Pessimistic: 1 week annual income
1.7 +21% Optimistic: $10 / dose

Vaccine cost 1.4 Base Case: $15 / dose
1.2 -14% Pessimistic: $20 / dose
1.43 +2% Optimistic: $4 / dose

Delivery cost 1.4 Base Case: $5 / dose
1.34 -14% Pessimistic: $16 / dose
Optimistic
Base case 0 5 10 15 20

Base Case
Sensitivity
Efficacy
Affordability
Cost

DEMAND FOR AN 80% EFFICACIOUS VACCINE AS HIGH AS 17
MM PEOPLE IN 2025
Private market demand for varying vaccine
efficacy levels (2025) Key messages
Efficacy profile
Efficacy has a significant impact on vaccine
demand
80% clinical, • Demand for 80% efficacious vaccine is
17.4
80% severe more than 10 times that for a 50%
efficacious vaccine
Uptake driven by a combination of factors

50% clinical, • Efficacy thresholds at which vaccine is
1.4
50% severe accepted in a country
- e.g., uptake in Thailand requires 80%
efficacy
• Affordability of vaccine to country
30% clinical, populations based on projected income
0
50% severe distributions
• Population size of countries
0 2 4 6 8 10 12 14 16 18 20 Majority of demand for 80% efficacious
# of people (MM) vaccine from outside Africa
S & SEA Eastern Europe
Africa Eastern
Mediterranean
Americas
Base Case
Sensitivity
Efficacy
Affordability
Cost

EARLY APPROVAL AND INTRODUCTION COULD INCREASE
DEMAND BY 3.9 MM PEOPLE BETWEEN ’10 AND ’25
Private market demand for a 50% efficacious vaccine - People (2010-2025)
# of people
(MM)
1.6
1.4
1.2
Incremental demand
due to early
1 introduction
0.8
Base case demand
0.6 Incremental demand

due to early
0.4 introduction
0.2
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25

Base Case
Sensitivity
Efficacy
Affordability
Cost

AS FEW AS 0.7 MN PEOPLE MAY BUY VACCINE IF THEY ARE
WILLING TO SPEND 1% OF ANNUAL INCOME
For A 50% Efficacious Vaccine
Private market demand at varying affordability levels for a 50% efficacious vaccine - People (2010-2025)
# of people (MM)
1.5
1 Demand
at 2
0.5 weeks of
annual
income
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of people (MM)
1.5 S & SEA
Southern Africa
1 Demand East Africa
at 1 week W&C Africa
0.5 of annual Eastern Europe
income Eastern
0 Mediterranean
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 Americas
# of people (MM)
1.5
1 Demand
at 1% of
annual
0.5
income
0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
Base Case
Sensitivity
Efficacy
Affordability
Cost

DEMAND RANGES BETWEEN 1.7 MM TO 1.0 MM PEOPLE FOR A
PRICE RANGE OF US$ 10 TO 30 PER DOSE
Funded demand for varying cost
levels of a 50% efficacious vaccine (2025) Key messages
Vaccine cost Private market demand driven by two
US$ 10 / sub-segments of the high income
dose
1.7 population in countries
• A very high income group which is
relatively price insensitive
• A relatively lower income group with
US$ 15 /
dose 1.4 sufficient discretionary income to
afford a vaccine, but which is
sensitive to price
US$ 30 / Results in relatively low price
1.0
dose sensitivity when compared to the public
market
0 0.5 1 1.5 2
# of people
Majority of demand for a 50%
S & SEA Eastern Europe (MM) efficacious vaccine comes from Africa
Southern Africa Eastern across cost levels
W&C Africa Americas
SUMMARY OF PRIVATE MARKET DEMAND
1.4 MM people likely to buy a 50% efficacious vaccine, 70% from Africa
Base Case • Uptake likely to begin 3 years after approval
• Limited uptake from regions outside Africa where higher efficacy needed
Demand for an 80% efficacious vaccine as high as 17 MM people in 2025
• Efficacy has a significant impact on vaccine demand
• Demand for 80% efficacious vaccine is more than 10 times that for a 50%
efficacious vaccine
Efficacy • Majority of demand for 80% efficacious vaccine from outside Africa
• Uptake driven by a combination of factors
- Efficacy thresholds at which vaccine is accepted in a country
- e.g., uptake in Thailand requires 80% efficacy
- Affordability of vaccine to country populations based on projected
income distributions
Time of Early approval and introduction of vaccine, within 1 year of vaccine approval, could
introduction increase demand by 3.9 MM people between 2010 and 2025
0.7 MM people may buy vaccine if they are willing to spend 1% of annual income, as
Affordability compared to 1.4 MM people if they are willing to spend 2 weeks of annual income
Demand ranges between 1.7 MM to 1.0 MM people for a price range of US$ 10 to 30 per
dose, as compared to 1. 4 MM people for a US$ 15 per dose vaccine
• Private market demand driven by two sub-segments of the high income
Cost population in countries
- A very high income group which is relatively price insensitive
- A relatively lower income group with sufficient discretionary income to
afford a vaccine, but which is sensitive to price
Sensitivity Demand estimates most sensitive to efficacy

TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market

• Public market
• Private market
• Military market
Appendix
TRAVELERS MARKET LIKELY TO RANGE
BETWEEN 1.7 AND 3.3 MM PEOPLE IN 2025
Demand ranges from 1.7 MM to 3.3 MM Demand sensitivity highest to time in-country
people in 2025 required to generate interest in vaccine
Demand forecast for travelers market Sensitivity analysis for travelers market (2025)
(# of people
MM)
12 11.4
3.3
10 Stay in country for
> 4 w eeks
1.7
8 7.5
6
3.9 3.8
4 3.3 6.5
Stay in country for
2.6 > 2 w eeks
1.7 3.7
2 1.3 1.0
0.6
0
Num ber of Projected Num ber of Num ber of Num ber of
0 5 10
travelers w ho dem and travelers w ho travelers w ho travelers w ho
take assum ing take plan 4-8 take
(# of people MM)
prophylaxis current Hep A prophylaxis w eeks in prophylaxis
2025 im m unization and stay > 2 advance and and stay > 4 Plan 4 – 8 weeks in advance
rates w eeks stay > 4 w eeks
2015 w eeks Take prophylaxis
Peak
Peak demand
demand likely
likely to
to be
be in
in the
the range
range of
of 1.7
1.7 and
and 3.3
3.3 MM
MM people
people in
in 2025
2025
•• However
However close
close to
to 100%
100% efficacious
efficacious vaccine
vaccine required
required
•• Sensitive
Sensitive to
to in-country
in-country stay
stay assumptions,
assumptions, cost
cost and
and administration
administration schedule
schedule
Note: Assuming one arrival per traveler per country per year
60% OF DEMAND IN TRAVELERS MARKET LIKELY
TO BE FROM EUROPEAN TRAVELERS
# of people
Driven By Higher Rate Of Prophylaxis Use
(MM) Estimated vaccine demand by origin of traveler’s - People (2010-2025)
4.0
3.5
3.0
2.5
Base Case
2.0
1.7
1.5
Demand based on travelers who take
prophylaxis for malaria and stay
1.0 longer than 4 weeks in country
0.5
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of people
(MM) Estimated vaccine demand by origin of traveler’s -– Doses (2010-2025)
4.0
3.5 3.3
3.0
Demand based on travelers who plan
2.5
4-8 weeks in advance and stay > 4
2.0 weeks
1.5
1.0
0.5
Americans
0.0
Europeans
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
Note: Assuming one arrival per traveler per country per year Asians
DEMAND FOR A VACCINE IN THE RANGE OF 1.2 MM IF 10% ARE
FREQUENT TRAVELERS WITH 3 ARRIVALS / YEAR
# of people
(MM) Estimated vaccine demand by origin of traveler’s - People (2010-2025)
4.0
3.5
3.0
Base Case
2.5
2.0 prophylaxis for malaria and stay
1.7
longer than 4 weeks in country
1.5
100% of travelers arrive once / year /
1.0
country
0.5
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of people
(MM) Estimated vaccine demand by origin of traveler’s -– Doses (2010-2025)
4.0
3.5
3.0 prophylaxis for malaria and stay
2.5 longer than 4 weeks in country
2.0 90% of travelers arrive once / year /

country, 10% of travelers arrive 3
1.5 times / year / country
1.2
1.0
0.5 Americans
0.0 Europeans
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25 Asians
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market

• Public market
• Private market
• Military market
Appendix
PEAK ANNUAL DEMAND FOR A MALARIA VACCINE IN THE
MILITARY RANGES FROM 0-13 MM THROUGH 2025
2025 Scenarios Significant impact of efficacy on demand
Non-endemic country
militaries
Efficacy Against # of people (MM) Endemic country militaries
Clinical Disease 14
12.5
12
12.5MM 2.9MM 2.5MM 10

> 80% 6.1
8
6
6.4
50- 80% 0.8MM 0.8MM 0.3MM 4 2.9
2.5
2 0.9
0.3 0.8
0
H C / LE M C / LE LC / LE HC / M E MC/ME LC / M E HC / HE M C / HE LC / H E
< 50% 0 0 0 Cost High Med Low High Med Low High Med Low
Efficacy Low Med High

Scenarios
<$20 $20-$100 >$100 Key:
Total Vaccine Cost
Cost: Low - < $ 20, Med - $ 20 – 100, High - > $ 100
Efficacy: Low - < 50%, Med – 50 – 80%, High - > 80%
Military
Military demand
demand sensitive
sensitive to
to efficacy
efficacy and
and cost
cost
EFFICACY OF VACCINE HAS SIGNIFICANT IMPACT ON MARKET
12.5 MM People Likely to Receive a 80% Efficacious Vaccine
Estimated military market demand for a US$ 15/ dose vaccine - People (2010-2025)
# of 14.0
people
(MM) 12.0
10.0 Vaccine efficacy:
8.0 50% against clinical and 50% against

severe disease
6.0
4.0
2.0
0.7
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of 14.0
people 12.5
(MM) 12.0
Vaccine efficacy:
10.0
80% against clinical and 80% against
8.0
severe disease
6.0
Non-endemic country
4.0 militaries
2.0 Endemic country militaries
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
DEMAND FOR A US$ 50 / DOSE VACCINE LIKELY TO BE
RESTRICTED TO NON-ENDEMIC COUNTRY MILITARIES
# of 4.0
people
(MM) 3.5
3.0
Vaccine efficacy:
2.5
2.0 severe disease
1.5
1.0
0.7
0.5
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
# of 4.0
people
(MM) 3.5
Vaccine efficacy:
3.0 2.8
2.5 severe disease
2.0
1.5
Non-endemic country
1.0 militaries
0.5 Endemic country militaries
0.0
'10 '11 '12 '13 '14 '15 '16 '17 '18 '19 '20 '21 '22 '23 '24 '25
SUMMARY OF TRAVELERS AND MILITARY MARKET DEMAND
Travelers market likely to range between 1.7 and 3.3 MM people in 2025
• However efficacy needs to be close to 100%, similar to existing
chemoprophylaxis
• Only travelers who stay longer than 2 - 4 weeks and who plan at least 4
Travelers
weeks in advance likely to consider a vaccine
market • Demand is sensitive to assumptions around average number of trips per
person per year
60% of demand in travelers market likely to be from European travelers
Military market likely to be in the range of 0.7 MM people in 2025 for a 50%
efficacious vaccine costing US$ 15 / dose
• Demand likely only from non-endemic country militaries at 50% efficacy
levels
• Demand for a US$ 50 / dose vaccine likely to be restricted to non-endemic
country militaries
Military Higher efficacy of vaccine has significant impact on military market

market • 12.5 MM people likely to receive a 80% efficacious vaccine at US$ 15 /
dose as compared to only 0.7 MM people for a 50% efficacious vaccine
Cost of vaccine impacts demand for the vaccine, especially from armies with
relatively lower health care budgets
• Number of people receiving an 80% efficacious vaccine would reduce
from 12.5 MM to 2.8 MM people (in 2025) if cost of vaccine was US$ 50 /
dose instead of US$ 15 / dose
TABLE OF CONTENTS
Project overview

• Malaria burden
• Public market
• Private market
Appendix
BASE CASE DEVELOPED USING BEST CURRENT KNOWLEDGE
Can Become More Specific As Vaccine Candidates Progress Toward Licensure
Model structure has been developed to allow it to be an adaptable, living tool

• Inputs and assumptions can be dynamically changed
Assumptions for data and attitudes will continue to be refined as new information
is obtained over time
As we learn more about the emerging product profile of a specific vaccine

candidate, we will be able to more accurately predict expected demand
Although
Although we
we cannot
cannot pinpoint
pinpoint aa single
single specific
specific demand
demand “answer”,
“answer”, there
there are
are common
common
themes
themes that
that we
we believe
believe will
will continue
continue to
to most
most heavily
heavily drive
drive demand
demand over
over time
time

FOUR CENTRAL THEMES EMERGED ACROSS MARKETS
Substantial need/potential demand exists across all four markets examined
Specific requirements for product profile exist and vary significantly by country
• Efficacy thresholds
• Minimum duration to be considered
• Species of malaria
Ease of access will drive uptake, especially EPI program suitability
Third parties play an influential role

• Donor community
• Local and global scientific communities

KEY FINDINGS BY MARKET
Given Development Timelines, Important to Focus On Developing Desired
Product Profile And Influencing Public Market Attitudes
• Burden high • There is role for • Desire for • Use of portfolio

PUBLIC
PUBLIC throughout Africa, partial efficacy administration approach to
MARKET
MARKET in border areas • W Africa 50% vs. E through EPI fight malaria
elsewhere Africa 80% program • WHO support
• Duration > 1 yr • Donor funding
• Cost critical • Need for local
clinical data
• Burden high • Efficacy of 50% due • Limited by • Willingness to

PRIVATE
PRIVATE throughout Africa, to alternatives individual pay for private
MARKET
MARKET in border areas • Duration > 1 yr income, access health services
elsewhere to clinics
• Travelers to • Must have efficacy • Relevant for • Will likely prefer

TRAVELERS
TRAVELERS malaria endemic greater than or travelers who vaccine over
regions increasing equal to prophylaxis seek pre-travel prophylaxis for
advice longer trips
• Low prophylaxis • Mission comes first,
MILITARY
MILITARY compliance and need high clinical • Reach during • Vaccinate if
desire for efficacy basic training or helps mission
readiness gives • No side effects before
high need • Min duration 4-6 mo deployment
THREE FACTORS MOST INFLUENCE
FUTURE SUCCESS OF MALARIA VACCINE
Product profile has the strongest influence on demand, as the vaccine must reach
stated thresholds to have any uptake
Product • Efficacy and cost are key drivers, demand in the public market expected to
profile be:
- 71 MM people with clinical and severe efficacy of 50%, growing to 154
MM at ~80%
- 50 MM additional people could be funded if cost of vaccine was lowered
from $7 to $2 per dose
• P. falciparum component and one year duration are important minimum
requirements
Donor funding can drive demand by stimulating early markets and enabling less
wealthy countries’ purchase and administration of vaccine
Funding • Public markets will rely heavily on sustainable funding to introduce vaccine
- uptake only 7 MM people in base case scenario without donor funding
• With strong donor advocacy and implementation support, demand in the
public market could reach 290 MM people with clinical and severe efficacy of
80%
• Private markets likely to lag public markets since they do not “turn on” until
higher efficacy level reached
- unlikely to be achieved in first generation vaccine
Support of WHO, academics, and standards-setting organizations are key to

vaccine’s introduction and credibility
Influencer • Support of key third-party organizations can influence lag between licensure
support and introduction
• Countries and donors both both rely on key opinion leaders and WHO
recommendations in deciding on which interventions to support

TABLE OF CONTENTS
Project overview
Appendix
• Detailed description of demand model
• Primary research sources
• Secondary research sources
• Contact information
MODEL FOLLOWS THE DEMAND LEAKAGE FRAMEWORK
FOR ASSESSING MARKET POTENTIAL
A Need B Product C Access D Attitude
# of
doses
Public: A1 Which countries? B1 How does product C1 Target population D1 Vaccinate none E How many
coverage / donor versus high risk doses of
profile influence? vaccine in
funding available? versus infants
versus children a given
versus all? year does
this
Private: A2 Which individuals? B2 How does product C2 Private clinics/ D2 Use private market translate
ability to pay? for vaccine? into?
profile influence?
Travelers:A3 Which travelers? B3 How does product C3 Individuals seek D3 Prefer nothing
pre-travel advice? versus chemo-
profile influence? prophylaxis or
vaccines?
Military: A4 Which militaries? B4 How does product C4 Military budget D4 Vaccinate none
profile influence? sufficient? versus all versus
deployed only?
A1 WHAT COUNTRIES ACROSS THE WORLD NEED
QUESTION A1:
A MALARIA VACCINE?
Region Country MALARIA Population Birth cohort (Es Population < 5 (Est. GDP CAP
• Model contains a America Andean Bolivia 1 8,586,443 214,661 1,073,305 2,370
America Andean Colombia 1 41,662,073 1,041,552 5,207,759 6,519
master country data America Andean Ecuador 1 13,710,234 342,756 1,713,779 3,905
sheet America Andean Peru
America Andean Venezuela
1
1
28,409,897
24,654,694
710,247
616,367
3,551,237
3,081,837
4,888
6,402
• Lists all countries in America Brazil Brazil
America Mexico Mexico
1
1
182,032,604
103,718,062
4,550,815
2,592,952
22,754,076
12,964,758
7,537
8,903
the world Americas Belize 1 266,440 6,661 33,305 5,351
Americas Guyana 1 702,100 17,553 87,763 4,046
• Selects those that are Americas Suriname 1 435,449 10,886 54,431 4,217
Central Africa Cameroon 1 15,746,179 393,654 1,968,272 1,269
endemic to malaria Central Africa Central African Republic 1 3,683,538 92,088 460,442 1,289
Central Africa Chad 1 9,253,493 231,337 1,156,687 656
• Contains detailed data Central Africa Congo 1 2,954,258 73,856 369,282 1,036
on Central Africa Equatorial Guinea 1 510,473 12,762 63,809 5,239
Central Africa Gabon 1 1,321,560 33,039 165,195 5,514
- Economic profile Central Africa Sao Tome and Principe 1 175,883 4,397 21,985 954
Central America Costa Rica 1 3,896,092 97,402 487,012 7,838
and development Central America El Salvador 1 6,470,379 161,759 808,797 4,701
Central America Guatemala 1 13,909,384 347,735 1,738,673 4,144
- Population profile Central America Honduras 1 6,669,789 166,745 833,724 2,510
Central America Nicaragua 1 5,128,517 128,213 641,065 2,027
and growth Central America Panama 1 2,960,784 74,020 370,098 6,524
- Malaria related Central Africa
East Africa
Democratic Republic of th
Burundi
1
1
56,625,039
6,096,156
1,415,626
152,404
7,078,130
762,020
346
529
statistics East Africa Eritrea 1 4,362,254 109,056 545,282 629
East Africa Ethiopia 1 66,557,553 1,663,939 8,319,694 382
- Health care East Africa Kenya 1 31,639,091 790,977 3,954,886 1,452
East Africa Rwanda 1 7,810,056 195,251 976,257 799
statistics Eastern MediterranAfghanistan 1 28,717,213 717,930 3,589,652 660
Eastern MediterranDjibouti 1 457,130 11,428 57,141 1,288
Eastern MediterranEgypt 1 74,718,797 1,867,970 9,339,850 3,901
Eastern MediterranIran (Islamic Republic of) 1 68,278,826 1,706,971 8,534,853 6,673
Eastern MediterranIraq 1 24,683,313 617,083 3,085,414 2,997
All
All information
information on
on this
this sheet
sheet is
is based
based on
on data
data and
and fixed
fixed with
with respect
respect to
to the
the model
model

B1 HOW DOES POTENTIAL PRODUCT PROFILE
QUESTION B1:
DRIVE DEMAND? (I)
Duration of action
• Sheet captures a Disease
1
50%
2
50%
3
50%
4
50%
5
50%
6
50%
matrix that defines a Species of malaria
Falciparum
target
Clinical
Age-group
Infants
< 6 months 6 months
50% 50%
> 6 months to < 1 y 1 year
50% 50%
>1 to 5 year > 5 years
50% 50%
product profile Falciparum
Falciparum
Clinical
Clinical
Children 1 - 5 years
Children 5 + years
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
• All parameters on the Falciparum
Falciparum
Clinical
Clinical
Adults
Pregnant women
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
matrix are variable, Falciparum

Falciparum
Severe
Severe
Infants
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
allowing demand to be Falciparum

Falciparum
Severe
Severe
Children 5 + years
Adults
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
50%
estimated for a wide Falciparum

Vivax
Severe
Clinical
Pregnant women
Infants
50%
0%
50%
0%
50%
0%
50%
0%
50%
0%
50%
0%
range of profiles Vivax

Vivax
Clinical
Clinical
Children 5 + years
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
Combined Severe Children 5 + years
• Matrix captures the Combined Severe Adults
Combined Severe Pregnant women
interplay between
Dosage chart
- Efficacy Dosage # of
Initial dosage 3
- Duration of action Gap between doses 0 & 1 (months)
Gap between doses 1 & 2 (months)
1
1
- Target population Gap between doses 2 & 3 (months)
- Clinical Frequency of booster doses (once every _ months) 12
Applicable during pregnancy Yes
manifestation Dosage during pregnancy 3
- Dosage
Cost of vaccine Cost A Cost B Cost C
- Schedule Cost per dose in public market (US$)
# doses in initial administration
2
3
10
3
20
3
- Cost of vaccine Need for annual booster Yes Yes Yes
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

QUESTION B1:
DRIVE DEMAND? (II)
Minimum required to enter
Result for market type
market type
Cluster
Product profile
Id Country / Cluster Public Private Public Private
parameter Public Private
market market market market
• Product profile – Entry 1 Ghana cluster Efficacy / effect 30% 50% TRUE TRUE
Ghana cluster Duration of acti 12 12 1 1
sheet captures Ghana cluster Age-group All All
Yes Yes
research findings on Africa cluster 1 Cost of vaccine 5 5
minimum threshold 2 Nigeria cluster

Nigeria cluster
Efficacy / effect
Duration of acti
30%
12
50%
12
TRUE
1
TRUE
1 Yes Yes
required to enter Nigeria cluster Age-group All All
market TRUE
3 Senegal cluster Efficacy / effect 30% 50% TRUE Yes Yes
• Establishes whether Senegal cluster Duration of acti 12 12 1 1
vaccine will enter 4 Brazil cluster Efficacy / effect 80% 80% FALSE FALSE
Brazil cluster Duration of acti 12 12 2 2 No
market based on No
Brazil cluster Age-group All All
assumed product 5 Tanzania cluster Efficacy / effect 50% 60% TRUE FALSE
profile Tanzania cluster Duration of acti 12 12 1 2 Yes No
Tanzania cluster Age-group All All
• Captures information 6 Mozambique cluster Efficacy / effect 50% 60% TRUE FALSE
Mozambique cluster Duration of acti 12 12 1 2 Yes No
at the level of clusters Mozambique cluster Age-group All All
7 India cluster Efficacy / effect 80% 80% FALSE FALSE
India cluster Duration of acti 12 12 2 2 No No
India cluster Age-group All All
8 Thailand cluster Efficacy / effect 80% 80% FALSE FALSE
Thailand cluster Duration of acti 12 12 2 2 No No
Thailand cluster Age-group All All
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

QUESTION B1:
DRIVE DEMAND? (III)
Public market
Donor funding
availability (1 =
Government to self-
fund, 2 = Full % of total health
% of population that % of malaria spend
Cluster Id Country / Cluster availability of funds expenditure likely to
will be considered
from donors, 3 = be spent on malaria
likely on vaccine Intent to Intent to Intent to Annual
Partial funding vaccinate vaccinate vaccinate Intent to Compliance
available from Intent to vaccinate pregnant children 1 - children > vaccinate rate to
donors) children < 1 women 5 5 adults boosters
1 Ghana cluster 100% 1 30% 30% Yes Yes Yes No No 70%
2 Nigeria cluster 100% 1 30% 30% Yes Yes Yes No No 50%
3 Senegal cluster 100% 1 30% 30% Yes Yes Yes No No 70%
4 Brazil cluster 10% 1 10% 30% Yes Yes Yes Yes Yes 80%
5 Tanzania cluster 100% 1 30% 30% Yes Yes Yes No No 60%
6 Mozambique cluster 100% 1 30% 30% Yes Yes Yes No No 50%
7 India cluster 15% 1 15% 30% Yes Yes Yes No No 60%
8 Thailand cluster 5% 1 10% 30% Yes Yes Yes Yes Yes 80%
9 Americas HI 10% 1 10% 30% Yes Yes Yes Yes Yes 80%
10 Americas LI 10% 1 10% 30% Yes Yes Yes No No 80%
11 East Africa 100% 1 30% 30% Yes Yes Yes No No 60%
12 Eastern Mediterranean HI,L 15% 1 30% 30% Yes Yes Yes Yes Yes 60%
13 Eastern Mediterranean LI,L 15% 1 30% 30% Yes Yes Yes No No 60%
14 Eastern Mediterranean LI,H 100% 1 30% 30% Yes Yes Yes No No 60%
15 Europe LI,LB 5% 1 10% 30% Yes Yes Yes No No 80%
16 SEA HI,LB 15% 1 10% 30% Yes Yes Yes Yes Yes 80%
17 SEA LI,HB 100% 1 15% 30% Yes Yes Yes No No 60%
18 SEA LI,LB 15% 1 15% 30% Yes Yes Yes No No 60%
19 Southern Africa HI,LB 100% 1 30% 30% Yes Yes Yes Yes Yes 60%
20 Southern Africa LI,LB 100% 1 30% 30% Yes Yes Yes No No 50%
21 Southern Africa LI,HB 100% 1 30% 30% Yes Yes Yes No No 50%
22 West and Central Africa 100% 1 30% 30% Yes Yes Yes No No 60%
• Clustering methodology used to extrapolate in-country research findings, especially

attitudinal parameters, to the malaria afflicted countries around the world
• Methodology based on malaria burden and country income levels
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

QUESTION B1:
DRIVE DEMAND? (IV)
South-East Asia
4000
Vulnerables All
3500
3000
Incidence of malaria / 100,000 pop.
2500
2000 South-East Asia
1500
30% efficacy
1000
500
80% efficacy
0
- 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000
GDP / capita USD
• Methodology based on malaria burden and country income levels

• Findings form in-country research segmented on the basis of above parameters
• Findings extrapolated to non-research countries
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

C1 IN THE PUBLIC MARKET, WHAT PROPORTION OF
QUESTION B1:
POPULATION IS LIKELY TO HAVE ACCESS TO THE VACCINE?
Define upper Run scenarios
Define rate of Run scenarios
threshold for around upper
uptake around uptake
coverage threshold
• For each country • Based on progress in • Based on historic EPI • Based on vaccine
individually economic and health data analogues
care indicators
• Based on historic EPI • Baseline defined as - e.g. baseline: DPT3
data • Using regression uptake of DPT3 average for region,
analysis, e.g. EPI average for region fast: HepB average
- for different vaccine
coverage as influenced where implemented
coverage, e.g. DPT3
by GDP/cap
as base-line coverage, • Based on scenarios
HepB as high • Using specific around funding
coverage where scenarios availability,
implemented, others sustainability planning,
etc.
100% 100% Sc. 2: 90% 100% Base-line 100%
80%
uptake
E.g. ~ 80% 80% Sc. 1: 70% 80%
based on
80%
60% in Ghana 60% 60% historic 60%
40% 40% 40% DPT3 40%
20% 20% 20% 20%
DPT3
0% 0% 0% 0%
0 n years 0 n years 0 n years 0 n years
EPI
EPI inputs
inputs are
are fixed,
fixed, all
all others
others are
are variables
variables
D1 BASED ON ATTITUDE OF GOVERNMENTS, WHAT
QUESTION B1:
PROPORTION OF POPULATION WILL BE TARGETED?
• Regional profile:
Population that will be
considered by
government to be Public market
targets for the vaccine

- E.g. Africa countries
% of population that
100%, Brazil 10%, Cluster Id Country / Cluster
will be considered Intent to Intent to Intent to
Thailand 5% vaccinate vaccinate vaccinate Intent to
Intent to vaccinate pregnant children 1 - children > vaccinate
• Demographic profile: children < 1 women 5 5 adults
100% Yes Yes Yes No No
Age-groups and 1 Ghana cluster
2 Nigeria cluster 100% Yes Yes Yes No No
demographic profiles 3 Senegal cluster 100% Yes Yes Yes No No
10% Yes Yes Yes Yes Yes
considered by the 4 Brazil cluster
5 Tanzania cluster 100% Yes Yes Yes No No
government for public 6 Mozambique cluster 100% Yes Yes Yes No No
15% Yes Yes Yes No No
market 7 India cluster
8 Thailand cluster 5% Yes Yes Yes Yes Yes
- E.g. Africa: <5s and
pregnant women,
Thailand all age-
groups
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

D1 BASED ON ATTITUDE OF GOVERNMENTS AND
QUESTION B1:
DONORS, WHAT PROPORTION OF FUNDING WILL BE
AVAILABLE FOR A MALARIA VACCINE?
Cost-Effectiveness Profiles
Cost of vaccine Efficacy of vaccines

Parameter compared to ITNs Notes compared to ITNs Notes
Vhigh 20 More than 2 X ITN cost 90% > 90%

• Cost-effectiveness in High 15 More than 1.5 X ITN cos 60% More than 2X of ITNs
Medium Within 50% of ITN cost Less than 2X of ITNs
comparison with other Low 7.5 Less than 50% of ITN co 30% Less than ITNs
interventions used to
Parameter (Cost) Parameter (Efficacy) Concatenate Result
estimate proportion of Low Low LowLow 10%
Medium Low MediumLow 10%
donor and country High Low HighLow 0
funding that could be Vhigh

Low
Low
Medium
VhighLow
LowMedium
0
50%
dedicated to a malaria Medium
High
Medium
Medium
MediumMedium
HighMedium
30%
20%
vaccine Vhigh
Low
Medium
High
VhighMedium
LowHigh
10%
60%
• Based on interview Medium

High
High
High
MediumHigh
HighHigh
50%
40%
findings donor Vhigh

Low
High
Vhigh
VhighHigh
LowVhigh
30%
80%
organizations and Medium
High
Vhigh
Vhigh
MediumVhigh
HighVhigh
80%
70%
country Ministries of Vhigh Vhigh VhighVhigh 60%
Finance Product profile

Efficacy lookup 50.0%
Cost lookup 8.67
Donor /country funding factor

Cost result Efficacy result Concatenate result Funding result
Medium Medium MediumMedium 30%
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

E1 HOW MANY DOSES OF VACCINE IN A GIVEN
QUESTION B1:
YEAR DOES THIS TRANSLATE INTO?
Parameters Year A Year B Year C Year D Year E
Birth cohort A1 x NI B1 x NI C1 x NI D1 x NI E1 x NI
& pregnant
women
A 2-5 x NI A 2-5 x NIB x A 2-5 x NIB x A 2-5 x NIB x A 2-5 x NIB x
Children Σ CF1 CF2 CF3 CF4
aged 1 – 5 Σ
years (B 2-5 - A 2-5) x Σ (B 2-5 - A 2-5) x (B 2-5 - A 2-5) x (B 2-5 - A 2-5) x
NI NIB x CF1 NIB x CF2 NIB x CF3
Σ
(C 2-5 - B 2-5) x (C 2-5 - B 2-5) x (C -B )x
NI NIB x CF1 Σ NIB 2-5
x CF2
2-5
(D 2-5 - C 2-5) x (D 2-5 - C 2-5) x

NI NIB x CF1
(E 2-5 - D 2-5) x
NI
Children > 5 Same as children 1 – 5, except progression does not stop after 5th year
and adults
Compliance
Compliance factor,
factor, number
number ofof initial
initial and
and booster
booster Ai = Population of age i in year A
doses
doses are
are variables.
variables. CFn = Compliance factor for cluster / country for nth year
NI = Number of initial doses
NIB = Number of booster doses / year
Structure
Structure similar
similar to
to public
public market
market
A2 WHAT COUNTRIES ACROSS THE WORLD NEED

QUESTION A1:
A MALARIA VACCINE?
Region Country MALARIA Population Birth cohort (Es Population < 5 (Est. GDP CAP
• Model contains a America Andean Bolivia 1 8,586,443 214,661 1,073,305 2,370
America Andean Colombia 1 41,662,073 1,041,552 5,207,759 6,519
master country data America Andean Ecuador 1 13,710,234 342,756 1,713,779 3,905
sheet America Andean Peru
America Andean Venezuela
1
1
28,409,897
24,654,694
710,247
616,367
3,551,237
3,081,837
4,888
6,402
• Lists all countries in America Brazil Brazil
America Mexico Mexico
1
1
182,032,604
103,718,062
4,550,815
2,592,952
22,754,076
12,964,758
7,537
8,903
the world Americas Belize 1 266,440 6,661 33,305 5,351
Americas Guyana 1 702,100 17,553 87,763 4,046
• Selects those that are Americas Suriname 1 435,449 10,886 54,431 4,217
Central Africa Cameroon 1 15,746,179 393,654 1,968,272 1,269
endemic to malaria Central Africa Central African Republic 1 3,683,538 92,088 460,442 1,289
Central Africa Chad 1 9,253,493 231,337 1,156,687 656
• Contains detailed data Central Africa Congo 1 2,954,258 73,856 369,282 1,036
on Central Africa Equatorial Guinea 1 510,473 12,762 63,809 5,239
Central Africa Gabon 1 1,321,560 33,039 165,195 5,514
- Economic profile Central Africa Sao Tome and Principe 1 175,883 4,397 21,985 954
Central America Costa Rica 1 3,896,092 97,402 487,012 7,838
and development Central America El Salvador 1 6,470,379 161,759 808,797 4,701
Central America Guatemala 1 13,909,384 347,735 1,738,673 4,144
- Population profile Central America Honduras 1 6,669,789 166,745 833,724 2,510
Central America Nicaragua 1 5,128,517 128,213 641,065 2,027
and growth Central America Panama 1 2,960,784 74,020 370,098 6,524
- Malaria related Central Africa
East Africa
Democratic Republic of th
Burundi
1
1
56,625,039
6,096,156
1,415,626
152,404
7,078,130
762,020
346
529
statistics East Africa Eritrea 1 4,362,254 109,056 545,282 629
East Africa Ethiopia 1 66,557,553 1,663,939 8,319,694 382
- Health care East Africa Kenya 1 31,639,091 790,977 3,954,886 1,452
East Africa Rwanda 1 7,810,056 195,251 976,257 799
statistics Eastern MediterranAfghanistan 1 28,717,213 717,930 3,589,652 660
Eastern MediterranDjibouti 1 457,130 11,428 57,141 1,288
Eastern MediterranEgypt 1 74,718,797 1,867,970 9,339,850 3,901
Eastern MediterranIran (Islamic Republic of) 1 68,278,826 1,706,971 8,534,853 6,673
Eastern MediterranIraq 1 24,683,313 617,083 3,085,414 2,997
All
All information
information on
on this
this sheet
sheet is
is based
based on
on data
data and
and fixed
fixed with
with respect
respect to
to the
the model
model

Structure
Structure similar
similar to
to public
public market
market

QUESTION B1:
DRIVE DEMAND? (II)
Minimum required to enter
Result for market type
market type
Cluster
Product profile
Id Country / Cluster Public Private Public Private
parameter Public Private
market market market market
• Product profile – Entry 1 Ghana cluster Efficacy / effect 30% 50% TRUE TRUE
Ghana cluster Duration of acti 12 12 1 1
sheet captures Ghana cluster Age-group All All
Yes Yes
research findings on Africa cluster 1 Cost of vaccine 5 5
minimum threshold 2 Nigeria cluster

Nigeria cluster
Efficacy / effect
Duration of acti
30%
12
50%
12
TRUE
1
TRUE
1 Yes Yes
required to enter Nigeria cluster Age-group All All
market TRUE
3 Senegal cluster Efficacy / effect 30% 50% TRUE Yes Yes
• Establishes whether Senegal cluster Duration of acti 12 12 1 1
vaccine will enter 4 Brazil cluster Efficacy / effect 80% 80% FALSE FALSE
Brazil cluster Duration of acti 12 12 2 2 No
market based on No
Brazil cluster Age-group All All
assumed product 5 Tanzania cluster Efficacy / effect 50% 60% TRUE FALSE
profile Tanzania cluster Duration of acti 12 12 1 2 Yes No
Tanzania cluster Age-group All All
• Captures information 6 Mozambique cluster Efficacy / effect 50% 60% TRUE FALSE
Mozambique cluster Duration of acti 12 12 1 2 Yes No
at the level of clusters Mozambique cluster Age-group All All
7 India cluster Efficacy / effect 80% 80% FALSE FALSE
India cluster Duration of acti 12 12 2 2 No No
India cluster Age-group All All
8 Thailand cluster Efficacy / effect 80% 80% FALSE FALSE
Thailand cluster Duration of acti 12 12 2 2 No No
Thailand cluster Age-group All All
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

C2 IN THE PRIVATE MARKET, WHAT PROPORTION
QUESTION B1:
IS LIKELY TO BE ABLE TO AFFORD THE VACCINE? (I)
Define per Develop income Estimate
Determine affordability
capita income distribution population sizes
levels
and growth pyramids with income levels
• For each country • For geographic regions • Based on interview • Develop regression
individually findings model to estimate % of
- E.g. Sub-Saharan
population with a level of
• Determine per capita Africa, East Africa, • Determine
income high enough to
income and growth rates etc. affordability levels
Income as % of average
purchase vaccine
COUNTRY_NAME Growth rate 2003 GNI p
Albania 15.7% 1740 per capita income - What % of per
Algeria 5.3% 1890
Angola 14.5% 740 250%
capita income likely 120%
Antigua and Barbuda
Armenia
2.4%
10.8%
9160
950
to be spent on 100%
Australia 0.9% 21650
200% malaria vaccine 80%
Austria 0.6% 26720
Azerbaijan
Bahamas, The
9.2%
1.6%
810
15110
- E.g. 2 weeks 60%
150% y = 0.006x3 - 0.1675x2 + 0.8268x - 0.1402
Kingdom of Bahrain 3.7% 11260 income, 1% of 40%
R2 = 0.9853
Bangladesh 2.0% 400
Barbados 1.7% 9270 annual income, etc. 20%
Belarus 3.0% 1590 100%
Belgium
Belize
0.7%
1.9%
25820
3190
• Develop scenarios for 0%
Benin 3.1% 440 50% various cost levels of -20%
0% 50% 100% 150% 200% 250% 300%
Bhutan 8.9% 660
Bolivia -2.6% 890 the vaccine
Bosnia and Herzegovina 5.6% 1540 0% 10% 20% 30% 40%
Botswana 3.3% 3430
% of population with income
Brazil -8.7% 2710
level
Income
Income levels
levels and
and growth
growth are
are fixed,
fixed, income
income pyramids
pyramids and
and affordability
affordability inputs
inputs are
are variables
variables
C2 IN THE PRIVATE MARKET, WHAT PROPORTION
QUESTION B1:
IS LIKELY TO BE ABLE TO AFFORD THE VACCINE? (II)
Affordability model for private sector uses multiple regression equations
3rd degree polynomial regression 101%

equation used to model 100%
y = 0.0015x + 0.9225
R2 = 1
affordability till 3 X of average 99%
income 98%
97%
96%
120%
95%
100% 94%
80% 93%
92%
60% 0% 1000% 2000% 3000% 4000% 5000% 6000%
y = 0.006x3 - 0.1675x2 + 0.8268x - 0.1402
40%
R2 = 0.9853
20% 100%
y = 5E-07x + 0.9995
100% R2 = 1
0%
100%
0% 50% 100% 150% 200% 250% 300%
-20% 100%
100%
100%
100%
Linear equations used to model 100%
affordability > 3 X of average income 0% 20000% 40000% 60000% 80000% 100000 120000
% %

D2 BASED ON ATTITUDES IN PRIVATE MARKET,
QUESTION B1:
WHAT PROPORTION OF POPULATION WILL BE TARGETED? (II)
• Population likely to
need vaccine given
distribution of malaria Private market
and attitudes
Uptake Uptake Uptake Uptake
• Given coverage by % of
likely from likely from likely from likely from Uptake
population that
public market, portion Cluster Id Country / Cluster
will be private private private private likely from
interested
that will procure market for market for market for market for private
children < pregnant children 1 - children > market for
vaccine in private 1 women 5 5 adults
market 1 Ghana cluster 100% No No No Yes Yes
2 Nigeria cluster 100% No No No Yes Yes
- Adjustments made 3 Senegal cluster 100% No No No Yes Yes
for high-income 4 Brazil cluster 10% No No No Yes Yes
families who prefer 5 Tanzania cluster 100% No No No Yes Yes
6 Mozambique cluster 100% No No No Yes Yes
private vaccination 7 India cluster 100% No No No Yes Yes
8 Thailand cluster 5% No No No Yes Yes
• Portion of population
with access to private
vaccination
All
All inputs
inputs on
on this
this sheet
sheet are
are variables
variables

Structure
Structure similar
similar to
to public
public market
market
E2 HOW MANY DOSES OF VACCINE IN A GIVEN

QUESTION B1:
YEAR DOES THIS TRANSLATE INTO?
Parameters Year A Year B Year C Year D Year E
Birth cohort A1 x NI B1 x NI C1 x NI D1 x NI E1 x NI
& pregnant
women
A 2-5 x NI A 2-5 x NIB x A 2-5 x NIB x A 2-5 x NIB x A 2-5 x NIB x
Children Σ CF1 CF2 CF3 CF4
aged 1 – 5 Σ
years (B 2-5 - A 2-5) x Σ (B 2-5 - A 2-5) x (B 2-5 - A 2-5) x (B 2-5 - A 2-5) x
NI NIB x CF1 NIB x CF2 NIB x CF3
Σ
(C 2-5 - B 2-5) x (C 2-5 - B 2-5) x (C -B )x
NI NIB x CF1 Σ NIB 2-5
x CF2
2-5
(D 2-5 - C 2-5) x (D 2-5 - C 2-5) x

NI NIB x CF1
(E 2-5 - D 2-5) x
NI
Children > 5 Same as children 1 – 5, except progression does not stop after 5th year
and adults
Compliance
Compliance factor,
factor, number
number of
of initial
initial and
and booster
booster Ai = Population of age i in year A
doses
doses are
are variables.
variables. CF
CF separate
separate forfor public
public and
and CFn = Compliance factor for cluster / country for nth year
private
private markets
markets NI = Number of initial doses
NIB = Number of booster doses / year
METHODOLOGY AND ASSUMPTIONS FOR TRAVELERS MARKET
A3 Traveler market need determined by WTO international tourism statistics from the developed
world to malaria endemic regions as defined by the WHO
• To determine the number of travelers at risk for malaria, countries were clustered
depending on rate of traveler mobility to high-risk malaria regions (rural areas,
jungle/bush, provinces with high indices of malaria)
B3 Model assumes minimum product profile requirements/thresholds for vaccine adoption

• Assumptions include: efficacy requirement of 98%, 5 week malarone cost of $200, and
a vaccine that requires three doses
C3 Pre-travel medical advice and prophylaxis use drawn from traveler behaviour studies from the
Journal of Travel Medicine
D3 For purpose of scenarios travelers were grouped by planning and duration habits
• Travelers who take prophylaxis
• Projected uptake based on current Hep A immunization rates
• Travelers who take prophylaxis and stay in destination for over 2 weeks
• Travelers who plan 4-8 weeks in advance and stay in destination for over 4 weeks
• Travelers who take prophylaxis and stay in destination for over 4 weeks
D3 Uptake of vaccine assumed to be similar to private market uptake curve

E3 TRAVELER MARKET TRIANGULATION
Hep A Proxy
Travelers from developed world to high-risk areas 22 M
in malaria endemic countries
% of American travelers that get Hep A vaccine 14%
% of European travelers that get Hep A vaccine 37%
% of Asian travelers that get Hep A vaccine 5%
Total travelers from developed world that got Hep A vaccine in 2002 4.5 M
Malarone Sales
Total global prophylaxis sales in 2004 $290 M
Total global malarone sales in 2004 $78 M
Average duration of travel 18 Days
~ Cost of malarone per day $5
Total number of travelers that took malarone in 2004 .9 M
(1)Travelers to areas where they are at risk of contracting Hep A, ‘developed world’ refers to travelers from Asia, Europe, and the Americas as defined by WTO
(2)Duration of travel based on Journal of Travel Medicine studies covering Asian, U.S. and European travelers
MILITARY NEED SEGMENTED INTO NUMBER OF TROOPS LIKELY
TO RECEIVE VACCINATION
A4 Militaries need vaccinations to maximise troop readiness and avoid illness
Three primary options for choosing a population to vaccinate:

1) All troops
2) No troops
3) Troops deployed to malaria-endemic regions
Snapshot: Deployment sizing in the model

Sample: Countries without Sample: Countries w/ malaria: same
malaria: ~5% deployed % as pop. at risk are deployed
Belgium Algeria
Canada Cambodia
Japan Dijibouti
Poland Ethiopia
UK Malaysia
US Saudi Arabia

VACCINE COST AND EFFICACY INFLUENCE MILITARY DEMAND,
SAFETY AND DURATION ACT AS THRESHOLD CRITERIA
B4
Vaccine efficacy and cost are key demand variables and were segmented
into three tiers
Vaccine Efficacy
(Clinical) Vaccine Cost (total)
Low (<50%) Low (< $20)
Medium (50-80%) Medium ($20-$100)
High (>80%) High (>$100)
Duration and safety are threshold criteria—militaries are unlikely to accept a

vaccine that lasts <6 months or one with serious side-effects

MILITARY BUDGETS DRIVE ABILITY TO PAY FOR VACCINE
C4 Military expenditure levels segmented into three tiers
Snapshot: Top 25 spending / active member

300
$ Spent / Member
(In thousands) 250
High budget
200
150
100 Medium budget
50
Low budget
0
Russia
UAE
UK
US
Australia
Italy
China
Indonesia
Libya
Spain
Czech
Israel
Portugal
Netherlands
France
S. Korea
Germany
Croatia
Ukraine
Japan
Saudi Arabia
Canada
Greece
Sweden
Taiwan
US
USDOD
DODspends
spends~$15-17B
~$15-17Beach
eachyear
yearfor
forthe
theDefense
Defense
Health Program, or ~$6,000/person
Health Program, or ~$6,000/person
Source: US Dept. of Defense, IISS “Military Balance,” World Military Expenditures and Arms Transfers” Bureau of Arms Control, Center for Disease Information
PEAK ANNUAL DEMAND FOR A MALARIA VACCINE IN THE
D4 MILITARY RANGES FROM 0-13 MM THROUGH 2025
2015 2015
> 80% 7.7MM 1.6MM 1.3MM
Scenarios # of people (MM) 2025
Significant impact of efficacy on demand

50- 80% 0.5MM 0.5MM 0.2MM 8
Efficacy Against 6
0 0 0
Clinical Disease < 50% 5
<$20 $20-$100 >$100 4

Total Vaccine Cost
3
2
2025
Scenarios > 80% 12.5MM 2.9MM 2.5MM 1
0
50- 80% 0.8MM Cost High Med Low High Med Low High Med Low
0.8MM 0.3MM
Efficacy Low Med High
Scenarios
Efficacy Against 0 0 0
Clinical Disease < 50% Key:
Cost: Low - < $ 20, Med - $ 20 – 100, High - > $ 100
<$20 $20-$100 >$100
Efficacy: Low - < 50%, Med – 50 – 80%, High - > 80%
Total Vaccine Cost
Military
Military demand
demand sensitive
sensitive to
to efficacy
efficacy and
and cost
cost
ASSUMPTIONS: TIERING OF VACCINE EFFICACY AND COST,
E4
MILITARY BUDGETS AND DEPLOYMENT
Tiering of Scenarios Scenario Uptake Levels
Military Budget Vaccine Efficacy Vaccine Cost
Vaccine Efficacy Segmentation Segmentation Segmentation
Military Budget (Clinical) Vaccine Cost (total) Low Low Low
Low Low Medium
Low (<$50,000 / Low (<50%) Low (< $20) Low Low High
Active Member) Low Medium Low
Low Medium Medium
Medium (>$50,000 / Medium (50-80%) Medium ($20-$100)
Low Medium High
Active Member)
Low High Low
High (>$150,000 / High (>80%) High (>$100) Low High Medium
Active Member) Low High High
Medium Low Low
Medium Low Medium
Average Deployment Time: 120 days Medium Low High
% Newly Deployed in A Cycle: 40% Medium Medium Low
Medium Medium Medium
Medium Medium High
Medium High Low
Snapshot: Variables in military model Medium High Medium
Malaria % % Used (1- Potential Medium High High
Budget Efficacy Price Risk (1- Deployed Deployed, 2- New
High Low Low
Country Segmentation Segmentation Segmentation Yes, 0-No) to Malarial All, 0-None) Vaccines
Albania Low High Low 0 5% 2 6,828 High Low Medium
Algeria Low High Low 1 100% 2 128,281 High Low High
Argentina Low High Low 1 10% 2 0 High Medium Low
Armenia Low High Low 1 5% 2 5,222
Australia Medium High Low 0 5% 1 53,795 High Medium Medium
Austria Low High Low 0 5% 2 5,184 High Medium High
Azerbaijan Low High Low 1 5% 2 7,814 High High Low
High High Medium
High High High
Troops deploying to endemic regions

All active troops
TABLE OF CONTENTS
Project overview
Appendix
BRAZIL INTERVIEWS
Amazon Tropical Medicine Foundation (5 people)

FIOCRUZ (4 people)
Ministry of Health (3 people)
Hospital das Clinicas/University of Sao Paulo (3 people)
INPE– National Institute of Space Research
World Bank
WHO/PAHO
USAID

GHANA INTERVIEWS

Noguchi Memorial Institute (2 people)
GSK Ghana (2 people)
Food & Drugs Board
EPID Researcher
USAID
MEDEX
NPO-Malaria, WHO
Dodowa Health Research Institute
Malaria Consortium Office
National Malaria Control Office
Heath Research Unit, Ghana Health Service
National Malaria Control Programme
DFID
HACI-Ghana
Ghana Social Marketing Foundation

INDIA INTERVIEWS
GSK, India (3 people)

NVBDCP (2 people)
Epidemic Diseases Hospital and MRC (2 people)
UNICEF
WHO India
WHO SEARO
ICGEB
Ex Director, NAMP
National Institute of Health and Family Welfare
Universal Program of Immunization
Sir Dorabji Tata Center for Research in Tropical Diseases
Manipal Hospital
Vidarbha Hospital
Sangeetha Nursing Home

MOZAMBIQUE INTERVIEWS

World Vision (3 people)
UNICEF (2 people)
CISM (2 people)
Ministry of Planning and Finance (2 people)
Universidade de Eduardo Mondlane
Health Alliance International
Malaria, PSI
DFID
Save the Children
USAID
Ilha de Josina Community
WHO Mozambique
WHO AFRO
Child Survival Program, World Relief
Government health official, Maputo Province
Project Hope
Bethesda Clinic (private), Maputo
World Bank, Mozambique

NIGERIA INTERVIEWS
NIPRD (8 people)
Isolo General Hospital (5 people)
FMOH (4 people)
Zankli Medical Center (3 people)
House of Representatives, Committee on Health (3 people)
Lagos State Ministry of Health (3 people)
NAFDAC (2 people)
Lowanson Community Partners for Health (2 people)
Federal Capital Territory, Dept. of Public Health
Health Department, Gwagwalada Local Government
Universal Gaskiya Pharmacy Ltd.
National Programme of Immunization
GSK, West & Central Africa
Gwagwalada Local Government
National Assembly Clinic
Nigerian Medical Association
NIMR
RBM, WHO
UNICEF
USAID
DFID
Hope for AIDS and Life Outreach
SENEGAL INTERVIEWS

Bambey District Health Centre (2 people)
Fann Hospital (2 people)
PATH (2 people)
WHO (2 people)
BASICS
DERF
GSK
Hopital Aristide le Dantec Service au Pediatrie
UNICEF
USAID
World Vision

TANZANIA INTERVIEWS

St. Francis Hospital, Ifakara (5 people)
World Health Organization (3 people)
USAID (2 people)
National Institute for Medical Research
Ministry of Finance
Africa Region, World Bank
Muhimbili University School of Public Health
DFID
Tanzania FDA
African Malaria Network Trust
Ifakara Health Research & Development Centre, LSHTM
HealthScope Tanzania
Project Manager, Reproductive and Child Health, African Medical and Research
Ifakara Research and Development Centre
AAR (Tanzanian Health Insurance Provider/Private Clinic Operator)

THAILAND INTERVIEWS
Faculty of Tropical Medicine , Mahidol University (4 people)

MoPH (3 people)
Biogenetech Co. Ltd. (2 people)
Shoklo Malaria Unit, Mae Sod, Tak province
National Science and Technology Development Agency
Wellcome Trust Unit Bangkok
Department of Immunology & Medicine, AFRIMS
The Global Fund
Wellcome Trust Unit Bangkok
WHO SAE
Faculty of Tropical Medicine, Mahidol University

TRAVELER INTERVIEWS
Centers for Disease Control and Prevention (3 people)

Tropical & Geographic Medicine Ctr., Division of Infectious Diseases,
Massachusetts General Hospital
Infectious and Tropical Disease Dept., London School of Hygiene and Tropical
Medicine
Center for Travel and Tropical Medicine, Toronto General Hospital
London School of Hygiene and Tropical Medicine

MILITARY INTERVIEWS
WRAIR (3 people)
Sir Dorabji Tata Center for Research in Tropical Diseases
Consultant Public Health Physician, British Forces
GSK, former WRAIR

DONOR AND POLICYMAKER INTERVIEWS
GSK (7 people)
PATH (5 people)
WHO (3 people)
CDC (3 people)
DFID (3 people)
RBM (2 people)
USAID (2 people)
World Bank (2 people)
UNICEF (2 people)
JICA
Netherlands Ministry
GAVI
Global Fund
WHO AFRO
Initiatives on PPP for Health
NIH
Ifakara
STI
MMV
MIM
INTERVIEW TOPICS VARIED BY TARGET GROUP
Target Government Officials Physicians/KOLs Private market Donors and policymakers
Topics Overview of current Overview of current Experience with malaria in Overview of current
malaria situation and malaria situation household malaria situation
approach to prevention
and treatment View of current malaria Impact of malaria on Interventions that are
interventions and unmet productivity and other funded/supported and
Current funding for needs metrics rationale
malaria interventions
Methods by which patients Interventions currently Unmet needs
Process/rationale for access malaria care and used
resource allocation treatment Reactions to potential
Amount of money profile attributes and
Unmet needs Reactions to potential currently spent on malaria ranges
profile attributes and interventions and other
Reactions to potential ranges drugs/vaccines Assessment of private
product profile attributes market
and ranges Assessment of private High-level reactions to
market potential product Key influencers and other
Assessment of private attributes factors that will impact
market Key influencers that will demand
impact demand
Key influencers and other
factors that will impact
demand

TABLE OF CONTENTS
Project overview
Appendix
SECONDARY SOURCES
Brazil Ministry of Health Datatsus
Case study on the costs and financing of immunization services in Ghana (Abt Associates)
Center for Disease Information, Bureau of Arms Control “World Military Expenditures and Arms Transfers”
CDC Malaria Surveillance Report 2002
Countrywatch
DASA
DFID “Developing a Sustainable ITN Market in Mozambique” RFP, May 2004
DHS (1997 data)
Food and Agriculture Organization of the United Nations (2002 data)
GAVI
Ghana EPI Financial Sustainability Plan (GAVI)
Ghana Health Report
Heritage
IMS (2003 data)
India Ministry of Health Datatsus
Institute of Medicine of Natural Sciences
Journal of Travel Medicine, “Travel Health Knowledge, Attitudes and Practices among US Travelers”
Journal of Travel Medicine, “Travelers Knowledge, Attitudes and Practices on Prevention of Infectious
Diseases: Results from a Pilot Study”
Journal of Travel Medicine, “Travelers Knowledge, Attitudes and Practices on the Prevention of Infectious
Diseases”

SECONDARY SOURCES
LSHTM
Malaria Foundation International
MARA Technical Report (1998)
MICS data (1998-2001)
Mozambique Financial Stability Plan (GAVI)
National Malaria Control Program Health Facility and Community Survey 2004 (2003 data)
Naval Medical Research Institute
NIC (2000)
PAHO
Project Hope: A Study to Describe Barriers To Childhood Vaccination in Mozambique
Roll Back Malaria (Abuja criteria)
Survey of basic vaccine coverage in Thailand (2003)
Tanzania Ministry of Health
Thai Ministry of Public Health
The Africa Malaria Report (WHO/UNICEF 2003)
The Global Fund
The Southeast Asian Journal of Tropical Medicine and Public Health, Vol. 34, (4), 2003
U.S. Department of Defense
UK Department of Trade and Investment
UNICEF

SECONDARY SOURCES
US Census Bureau
US Department of Defense, IIS “Military Balance”
USAID
Virtual Naval Hospital
WHO: Life expectancy and infant mortality (2003)
WHOLIS
WHOSIS
World Bank
World Tourism Organization, “World Overview and Tourism Topics” (2003)

TABLE OF CONTENTS
Project overview
Appendix
CONTACT INFORMATION
MIV, PATH Central Number: 206-285-3500

Contact: Patricia Atkinson Roberts
BCG Central Number: 617-973-1200

Contacts: Wendy Woods, Dave Matheson

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MARKET ASSESSMENT FOR MALARIA VACCINES

Malaria market assessment study sponsored by

With funding from

70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt -1-

Endemic country findings

Travelers and military findings

Demand model methodology

Predicted vaccine market size

Implications and next steps

Analysis for malaria vaccines in general, not for

Market assessment conducted at one point in

70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt -4-

Need Product Access Attitude

Description Number of people Number of people Number of people Number of people

Example • Size of population • Species (P. • Country healthcare • Government support

70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt -5-

Conduct landscape scan Develop market insight Synthesize findings and

• Review secondary sources • Primary research in 8 • Conduct additional

70685-02-DC Meeting-Handout-19Jan05-BW-BOS.ppt -6-

Malaria-endemic regions are geographically P. falciparum of increasing importance in

Africa dominated by P. falciparum

P. falciparum accounts for nearly 80%

Eastern Europe, Caucasus, and Brazil

Quadrant I: Quadrant II:

Quadrant IV:Low High

Sample endemic Sample donor and Sample military Sample travelers

Demand over time

Endemic country findings

Travelers and military findings

Demand model methodology

Predicted vaccine market size

Implications and next steps

Malaria transmission cycle Basic facts

Population at risk – malaria is endemic in 117

Morbidity – malaria infects a minimum of 300 to

Mortality - between 1 and 2 MM people die

Health care – at least 10% of hospitalizations and

Costs – real costs in Africa are $1.8 B annually;

Plasmodium characteristics In addition to its prevalence in Africa, P. falciparum also

Malaria cases in 2003 (000s)

Endemic country findings

Travelers and military findings

Demand model methodology

Predicted vaccine market size

Implications and next steps

Need Product Access Attitude

• Population of • Product profile • Coverage of • Decision

Private • Population of • Product profile • Private clinic • Individual

• Travelers to • Product profile • Seek advice • Prefer vaccine

• Worldwide • Product profile • Military budget • Vaccinate all vs.

“...one of the most important

“...the most important vector borne

“Children, who are worst

“We saw malaria “Reported malaria cases

“Malaria control is the oldest

Source: BCG interviews, BCG analysis

Early recognition: Educate patients to recognize

Environmental clean-up: removal

Strategy Population at risk Diagnosis and

Source: BCG interviews, BCG analysis

• Minimum efficacy desired against Countries will compare

Duration impacts cost

Population • Relevant to infants, children, and Pregnant women and under